{
"NDC": [
{
"NDCCode": "59985-324-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-324-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0324-32",
"ProductNDC": "59985-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Mineral Absorption",
"NonProprietaryName": "Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Calcarea Sulphurica, Cuprum Metallicum, Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Iodium Purum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Sulphuricum, Selenium Metallicum, Silicea",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; COPPER; DIBASIC POTASSIUM PHOSPHATE; FERRIC PHOSPHATE; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SELENIUM; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Iron [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Facilitate the use of 16 minerals from your food and expensive supplements to maximize your investment. Minimizes leg cramps."
},
{
"NDCCode": "42571-324-11",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (42571-324-11) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (42571-324-32) ",
"NDC11Code": "42571-0324-11",
"ProductNDC": "42571-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211745",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide."
},
{
"NDCCode": "69230-324-32",
"PackageDescription": "7 PACKET in 1 CARTON (69230-324-32) / 17 g in 1 PACKET",
"NDC11Code": "69230-0324-32",
"ProductNDC": "69230-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214990",
"LabelerName": "Camber Consumer Care Inc",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210414",
"SamplePackage": "N",
"IndicationAndUsage": " relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "59985-300-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-300-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0300-32",
"ProductNDC": "59985-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Allergy Mold, Dust And Hay",
"NonProprietaryName": "Bovista Lycoperdon, Secale Cornutum, Ustilago Maydis, Wyethia Helenioides",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CLAVICEPS PURPUREA SCLEROTIUM; LYCOPERDON UTRIFORME FRUITING BODY; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT",
"StrengthNumber": "6; 30; 12; 12",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Mold, dust & hay spritz helpful for relief of allergy symptoms - sneezing, itching, dullness, stuffy head, runny eyes & sinuses."
},
{
"NDCCode": "59985-301-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-301-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0301-32",
"ProductNDC": "59985-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Anti-septic Cuts And Scrapes",
"NonProprietaryName": "Baptisia Tinctoria, Echinacea Purpurea, Nitricum Acidum, Thuja Occidentalis, Calendula Officinalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "BAPTISIA TINCTORIA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA WHOLE; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6; 30; 30; 6; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Speed healing of cuts, scrapes and pain. Diminishes scars. Contains a natural antiseptic."
},
{
"NDCCode": "59985-305-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-305-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0305-32",
"ProductNDC": "59985-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Burn Relief",
"NonProprietaryName": "Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria, Utrica Urens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA; URTICA URENS WHOLE",
"StrengthNumber": "30; 30; 30; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!."
},
{
"NDCCode": "59985-310-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-310-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0310-32",
"ProductNDC": "59985-310",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Irritable Eye Relief",
"NonProprietaryName": "Aluminum Oxide, Amylenum Nitrosum, Argentum Nitricum, Arsenicum Iodatum, Calendula Officinalis, Conium Maculatum, Euphrasia Officinalis, Physostigma Venenosum, Ruta Graveolens",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ALUMINUM OXIDE; AMYL NITRITE; ARSENIC TRIIODIDE; CALENDULA OFFICINALIS FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE",
"StrengthNumber": "6; 6; 6; 30; 6; 6; 6; 30; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Diminishes red, irritated, itchy dry eyes, discharge, eye fatigue, reading and computer strain."
},
{
"NDCCode": "59985-315-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-315-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0315-32",
"ProductNDC": "59985-315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Sunburn Relief",
"NonProprietaryName": "Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA",
"StrengthNumber": "30; 30; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Use orally and or topically for scarring, pain, blistering. Reduces peeling. FAST RELIEF!."
},
{
"NDCCode": "59985-322-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-322-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0322-32",
"ProductNDC": "59985-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Antihistamine Action",
"NonProprietaryName": "Apis Mellifica, Ledum Palustre, Vespa Crabro, Histamine, Cresolum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "APIS MELLIFERA; CRESOL; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO",
"StrengthNumber": "30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For red, hot, stinging, intense, itching allergy symptoms including bites, punctures, and hives."
},
{
"NDCCode": "59985-323-32",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (59985-323-32) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "59985-0323-32",
"ProductNDC": "59985-323",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Diminish Gluten Reactivity",
"NonProprietaryName": "Anatherum Muricatum, Avena Sativa, Arsenicum Album, Berberis Vulgaris, Dioscorea Villosa, Okoubaka Aubrevillei",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CHRYSOPOGON ZIZANIOIDES ROOT; DIOSCOREA VILLOSA TUBER; OKOUBAKA AUBREVILLEI BARK",
"StrengthNumber": "30; 30; 6; 30; 6; 6",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves the symptoms of abdominal pain, discomfort, gas and bloating following consumption of gluten and grains."
},
{
"NDCCode": "0338-0341-04",
"PackageDescription": "14 BAG in 1 CARTON (0338-0341-04) / 1000 mL in 1 BAG",
"NDC11Code": "00338-0341-04",
"ProductNDC": "0338-0341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardioplegic",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRA-ARTERIAL",
"StartMarketingDate": "20000421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075323",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
"StrengthNumber": "17.6; 325.3; 119.3; 643",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000421",
"SamplePackage": "N",
"IndicationAndUsage": "Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.",
"Description": "Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg and Sodium Chloride USP 643 mg in Water for Injection, USP. May contain HCl and/or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; Magnesium (Mg++) 32 mEq; Potassium (K+) 16 mEq; Sodium (Na+) 110 mEq; Chloride (Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl- 160 mEq and bicarbonate (HCO3-) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "0409-2012-32",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03) ",
"NDC11Code": "00409-2012-32",
"ProductNDC": "0409-2012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Hydrochloride",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20050614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074137",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050614",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including buprenorphine hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Buprenorphine hydrochloride is a partial opioid agonist. The chemical name of buprenorphine hydrochloride is 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy 18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol, hydrochloride [5α, 7α(S)]. Buprenorphine hydrochloride is a white powder, weakly acidic and with limited solubility in water. Buprenorphine hydrochloride injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration. Each mL of buprenorphine hydrochloride injection contains 0.324 mg buprenorphine hydrochloride (equivalent to 0.3 mg buprenorphine), 50 mg anhydrous dextrose, water for injection and HCl to adjust pH to 3.5 to 5.5. Buprenorphine hydrochloride has the molecular formula, C29H41NO4∙HCl and the molecular weight of 504.09. It has the following structural formula."
},
{
"NDCCode": "0409-7969-05",
"PackageDescription": "12 POUCH in 1 CASE (0409-7969-05) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-7969-11) ",
"NDC11Code": "00409-7969-05",
"ProductNDC": "0409-7969",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plegisol",
"NonProprietaryName": "Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL",
"StartMarketingDate": "20050728",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018608",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "119.3; 643; 17.6; 325.3",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050728",
"SamplePackage": "N",
"IndicationAndUsage": "Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.",
"Description": "Plegisol (Cardioplegic Solution) is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. It is a \"core solution\" intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; magnesium (Mg++) 32 mEq; potassium (K+) 16 mEq; sodium (Na+) 110 mEq; chloride (Cl‾) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH's of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl‾ 160 mEq and bicarbonate (HCO3‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Plegisol with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "24478-324-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (24478-324-06) / 180 mL in 1 BOTTLE",
"NDC11Code": "24478-0324-06",
"ProductNDC": "24478-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quillivant",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202100",
"LabelerName": "NextWave Pharmaceuticals, Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "900",
"StrengthUnit": "mg/180mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130104",
"SamplePackage": "N",
"IndicationAndUsage": "QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR contains in each 1 mL the equivalent of 5 mg of methylphenidate hydrochloride, present as methylphenidate (4.32 mg) complexed with sodium polystyrene sulfonate. Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate structure. C14H19NO2 Mol. Wt. 233.31. QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide."
},
{
"NDCCode": "65162-469-35",
"PackageDescription": "3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) ",
"NDC11Code": "65162-0469-35",
"ProductNDC": "65162-469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eluryng",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
"DosageFormName": "RING",
"RouteName": "VAGINAL",
"StartMarketingDate": "20191216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ETONOGESTREL; ETHINYL ESTRADIOL",
"StrengthNumber": ".12; .015",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191216",
"SamplePackage": "N",
"IndicationAndUsage": "FOR VAGINAL USE ONLY. EluRyng is indicated for use by females of reproductive age to prevent pregnancy.",
"Description": "EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent to translucent , colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol, USP (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, USP over a three-week period of use. EluRyng is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, USP. EluRyng is not made with natural rubber latex. EluRyng has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol, USP are 324.5 and 296.40, respectively. The structural formulas are as follows."
},
{
"NDCCode": "65219-258-10",
"PackageDescription": "10 POUCH in 1 CASE (65219-258-10) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (65219-258-01) ",
"NDC11Code": "65219-0258-10",
"ProductNDC": "65219-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardioplegic Solution",
"NonProprietaryName": "Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL",
"StartMarketingDate": "20220606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214623",
"LabelerName": "Fresenius Kabi, USA, LLC",
"SubstanceName": "POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "119.3; 643; 17.6; 325.3",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220606",
"SamplePackage": "N",
"IndicationAndUsage": "Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.",
"Description": "Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. It is a \"core solution\" intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; magnesium (Mg++) 32 mEq; potassium (K+) 16 mEq; sodium (Na+) 110 mEq; chloride (Cl‾) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH's of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl‾ 160 mEq and bicarbonate (HCO3‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "68084-947-32",
"PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-947-32) / 1 CAPSULE in 1 BLISTER PACK (68084-947-33) ",
"NDC11Code": "68084-0947-32",
"ProductNDC": "68084-947",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinine Sulfate",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151130",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021799",
"LabelerName": "American Health Packaging",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151207",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use: Quinine sulfate oral capsules are not approved for: : 1 Treatment of severe or complicated P. falciparum malaria. , 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)]. .",
"Description": "Quinine sulfate capsules are a cinchona alkaloid chemically described as cinchonan-9-ol, 6’-methoxy-,(8α,9R)-,sulfate (2:1) (salt), dihydrate with a molecular formula of (C 20H 24N 2O 2) 2H 2SO 42H 2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "59985-101-11",
"PackageDescription": "28.35 g in 1 JAR (59985-101-11) ",
"NDC11Code": "59985-0101-11",
"ProductNDC": "59985-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Turbo Arnica",
"ProprietaryNameSuffix": "Cream",
"NonProprietaryName": "Arnica Montana Hpus",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARNICA MONTANA WHOLE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/28.35g",
"Status": "Deprecated",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141001",
"SamplePackage": "N",
"IndicationAndUsage": "Used for injuries, sprains, sore muscles."
},
{
"NDCCode": "59985-103-12",
"PackageDescription": "1 JAR in 1 BOX (59985-103-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0103-12",
"ProductNDC": "59985-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Bug Bite Cream",
"NonProprietaryName": "Apis Mellifica, Ledum Palustre, Histamine, Vespa Crabro, Calendula Officinalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "APIS MELLIFERA; CALENDULA OFFICINALIS FLOWERING TOP; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO",
"StrengthNumber": "30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For bites, stings, hives, diminishing swelling, pain and itching from bees, wasps, and mosquitoes. KIDS FAVORITE!."
},
{
"NDCCode": "59985-105-12",
"PackageDescription": "1 JAR in 1 BOX (59985-105-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0105-12",
"ProductNDC": "59985-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Calendula Cream",
"NonProprietaryName": "Calendula Officinalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Speed healing of wounds, sores, acne sores and lips. Reduces scarring."
},
{
"NDCCode": "59985-108-12",
"PackageDescription": "1 JAR in 1 BOX (59985-108-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0108-12",
"ProductNDC": "59985-108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Blistering Relief Cream",
"NonProprietaryName": "Cantharis Vesicatoria, Chocolate, Calendula Officinalis, Natrum Muriaticum, Echinacea Angustifolia",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; COCOA; ECHINACEA ANGUSTIFOLIA WHOLE; LYTTA VESICATORIA; SODIUM CHLORIDE",
"StrengthNumber": "30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "For pain relief and accelerated healing of all blistering outbreaks around mouth and on lips/genitals."
},
{
"NDCCode": "59985-109-12",
"PackageDescription": "1 JAR in 1 BOX (59985-109-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0109-12",
"ProductNDC": "59985-109",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Irritable Skin Cream",
"NonProprietaryName": "Calcarea Sulphurica, Calendula Officinalis, Graphites Naturalis, Nux Vomica, Cresolum, Thuja Occidentalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "CALCIUM SULFATE ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; CRESOL; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "30; 30; 6; 30; 6; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Relief for dry, cracking, miserable skin ailments. Use to facilitate healing of psoriasis and eczema."
},
{
"NDCCode": "59985-113-12",
"PackageDescription": "1 JAR in 1 BOX (59985-113-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0113-12",
"ProductNDC": "59985-113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Spider Bite Cream",
"NonProprietaryName": "Carbo Animalis, Alcoholus, Loxosceles Reclusa, Lachesis Mutus, Hamamelis Virginiana, Calendula Officinalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ALCOHOL; CALENDULA OFFICINALIS FLOWERING TOP; CARBO ANIMALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LOXOSCELES RECLUSA",
"StrengthNumber": "30; 30; 30; 30; 12; 6",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "This remedy has affinity for minimizing the poisoning effect and diminishing the potential tissue damage allowing the wound to heal."
},
{
"NDCCode": "59985-114-12",
"PackageDescription": "1 JAR in 1 BOX (59985-114-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0114-12",
"ProductNDC": "59985-114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Sports Injury Cream",
"NonProprietaryName": "Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Staphysagria, Calcarea Phosphorica",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM WHOLE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "To diminish pain and inflammation of muscle, tendon, ligament, puncture wounds and bone injuries, including surgery, P.T., sports injuries and dentistry."
},
{
"NDCCode": "59985-118-12",
"PackageDescription": "1 JAR in 1 BOX (59985-118-12) / 28 g in 1 JAR",
"NDC11Code": "59985-0118-12",
"ProductNDC": "59985-118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Remedi Health Solutions",
"ProprietaryNameSuffix": "Arnica Cream",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ARNICA MONTANA WHOLE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/28g",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Higher potency, significantly faster acting than most creams on the market. For sore muscles, sprains, bruising & injuries. (Use Calendula on. open sores.)."
},
{
"NDCCode": "59985-217-22",
"PackageDescription": "100 PELLET in 1 DRUM (59985-217-22) ",
"NDC11Code": "59985-0217-22",
"ProductNDC": "59985-217",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Turbo Travel Sickness",
"ProprietaryNameSuffix": "Relief",
"NonProprietaryName": "Tabacum, Hpus,cocculus, Hpus,ipecacuanha, Hpus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "IPECAC; JATEORHIZA CALUMBA ROOT; TOBACCO LEAF",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140110",
"SamplePackage": "N",
"IndicationAndUsage": "Alleviate symptoms of travel sickness."
},
{
"NDCCode": "59985-611-61",
"PackageDescription": "46 VIAL, GLASS in 1 CASE (59985-611-61) / 100 PELLET in 1 VIAL, GLASS (59985-611-20) ",
"NDC11Code": "59985-0611-61",
"ProductNDC": "59985-611",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family I",
"ProprietaryNameSuffix": "Kit",
"NonProprietaryName": "30c Homeopathic Kit",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151230",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Chc Montana",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; ACTIVATED CHARCOAL; ALUMINUM OXIDE; ANAMIRTA COCCULUS SEED; ANTIMONY POTASSIUM TARTRATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA WHOLE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; DROSERA ROTUNDIFOLIA WHOLE; EUPHRASIA STRICTA; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM WHOLE; IPECAC; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA WHOLE; MERCURIC CHLORIDE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; RANCID BEEF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[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_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_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], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151230",
"SamplePackage": "N",
"IndicationAndUsage": "Aconite (Fright) First remedy used for a cold when exposed to cold weather or wind. Like fear of flying, fear following a frightful event or shock. Alumina (Dryness) Dryness of stool, skin, mouth, eyes, vagina, etc. Ant Crud (Skin Cracks and Roughness) Roughness and cracks in nose and mouth, excessive appetite, warts, nausea, vomiting from overeating, sunstroke. Ant Tart (Rattling Chest) Cold, flu, elderly, small children, birthing. Cough remaining following the flu, blue babies, pneumonia-like symptoms. Apis (Bees) Red, hot, puffy, swollen, kidney edema. Feels like stinging pain; very tender and intolerant of heat, (sunburn, minor allergic reactions). Has an antihistamine action. Arg Nit (Exploding) Headache, anxiety, sugar cravings, especially chocolate. Constant throat clearing. Always in a hurry, insomnia with thoughts stuck over and over in head. Gas and bloating pressure. Arnica (Bruised) Accidental blows, sprains, bruised feeling, overwork of muscles, head injury, strokes. Also in cream. For broken skin, use orally and go to calendula cream as an antiseptic topically. Arsenicum (Poisoning) Vomiting, diarrhea as if had eaten rotten food. Burning pains with restlessness, worse at midnight. Dislike being alone. When ill, say “I feel like I’m going to die.”. Belladonna (Violent) Red, hot, throbbing. So violent in nature you need to transport to hospital. Give remedy during transport. High Fevers, pain of horrible things like migraines and appendicitis. Bryonia (Worsened by any movement) Back pain, migraine-worse even for eye movement. Patient says “Don’t touch me!”. Calendula This flower, as a remedy, is VERY FAST acting. Healing of internal and external ulcerations. Used to wash wounds and promote accelerated healing. Available as pellets, cream and tonic. Cantharis (Burns) Burning on skin, burning urination, great for sunburns too. Take orally and apply Calendula to skin. Spritz available. Carbo Veg (Reviver) Cold, clammy, gasping for air, needs to be fanned, runs to open window to breathe. General indigestion from milk or fatty foods. Faint and cold. Also, cleanse for fumes. Chamomilla (Angry Fits) Irritable “as if” too much coffee, cranky like teething baby. Nothing pleases them during anger. Wants something and then pushes it away. Over sensitive to pain. Baby colic of angry mother! Ear infections and childhood ailments. China O (Malaria) Debility from loss of fluids like heavy menses, prolonged diarrhea, fever with sweats and chills, giving blood. Returns vitality. It is also useful in ringing of the ear and faintness. Cocculus (Nurses Remedy) Debility and sleeplessness from caring for others, especially relatives. Sleeplessness, rolling over in bed, jet lag. Dizziness and car sickness, as if drunk. Coffea Cruda (Jittery) “As if” too much caffeine. Sleeplessness from being over excited like kids at Christmas or day before vacation. If jittery literally from caffeine, take Nux Vomica or Chamomilla. Colocynthis (Colic) Better for bending double (babies draw knees up). Cramp like abdominal pains, vomiting, relieved by applying pressure and leaning forward. Gall bladder-like symptoms. Drosera (Cough until you gag!) Whooping cough. Spasms or cough so hard it can induce vomiting sticky mucus. Feels trapped. Euphrasia (Eyebrite) Great for eye redness (pink eye), hay fever, and allergies. Ferr Phos (Iron) First remedy for fever of unknown origin, bloody nosed, heavy periods, tiredness from iron-poor blood.*If fevers don’t respond, go to Aconite or Belladonna. Gelsemium (Yellow) First remedy for flu with yellow discharge, nervous, weak, shivering, restless with frequent urination. Performance anxiety with frequent urination or diarrhea proceeding. DT’s (withdrawals). Hepar Sulph (Infections) Green, thick mucus of children, ear infection start in left and go to right, sore throat as if a splinter, boils, acne, etc. Histaminum General itchy allergies of eyes and skin, general inflammations and hives. Hypericum (Nerve Pain) Pain of a smashed finger (like in a door!); shooting pains, pains of dental work. Ignatia (Hysterical) Helpful for funerals and grief from unexpected events. Ailments from disappointments in love and circumstances. Helps to think clearly. Ipecacuaha (Nausea) Sick feeling not relieved by vomiting. May appear with other symptoms of flu or pregnancy. Also, great for flu with cough. Kali Bi First remedy for sinus infection with sticky stingy discharge. Headache between brows. Ledum (Homeopathic Tetanus) Pain and infection of puncture wounds. Punctures include insect bites! (Wounds may feel cold and pain is relieved by cold.) Never well since puncture like allergy shots, diabetes pricking frequently. Tetanus nosode also available. Lycopodium (Bullied or the bully) Milk aggravates digestion. Patient avoids beans and cabbage family vegetables to diminish embarrassment of gas and bloating. Flatulence worse between 4-8 pm. Great remedy for hernia. Mag Phos (Cramps and Bleeding) General cramps and spasms of menses, leg and feet, better with heading pad, bath or massage. Bloody noses. Mercury (infections) Abscesses in bone and nails, teeth infected, strep-throats, wetness, sweat or drool always present – profuse salvation. Sensitive to heat and cold, like a thermometer. Nat Mur Indicated for coughing on attempting to speak. Good menopausal remedy. (See Ars and Alum or vaginally dry.). Nux Vomica (Business men’s remedy) Not limited to males. Pain as if hangover, overworked, rushed, perfectionism, eating poorly. Excessive coffee, fast food, demanding, cranky and all the ailments of the 20th Century lifestyle; heartburn, hemorrhoids, cranky indigestion results. Phosphorus (Cough) Rare symptoms when ill. Cold that quickly goes to the chest. Bloody discharges, bloody noses. Hoarseness, dry, hard cough with fever, develops quickly from a cold setting in the chest. Patient craves cold drinks. People who love attention!. Pulsatilla(Common Child’s Remedy) Ailments of children who are comforted being held. Changeable symptoms with weariness. Better in fresh air. Sick from rich and fried foods. Needy girls. Good PMS remedy. Need to be in a group, yielding personality. Pyrogenium (Sepsis) Infections that look scary- high fever with rapid pulse- poisoning. When other infection remedies not effective. Any discharges with odor of rotting meat (abscess, sinus infections, etc.). Rhus Tox (Tin Man) Achy joints worse in storms or drop in barometer. Itchy skin eruptions; better bathing and better heat (when worse bathing, see Sulfur). Ruta (Tendon Injuries) Soreness of tendons from injury or overuse. Tired eyes from reading or computer work. Carpel tunnel syndrome. Silicea (Removes Foreign Bodies) For splinters under fingernails, to remove dirt from a wound, promote suppuration of abscess. Silicea will surround foreign body with fluid and bring to the surface. Thin hair and nails – defective nutritional assimilation. Spongia Tosta (Coughs) Worse wind-dry barking cough, cough better with warm drinks, cardiac cough. Hoarseness, dry, burning constriction feeling. Staphysagria The most indicated remedy after surgery to heal the incision and diminish chance of infection. Burning urination following new partner. (Honeymoon cystitis). Infection from others. Sulfur (Skin Remedy) Dry skin eruptions, worse with heat of bed or shower. Hot flashes, sinus infections, yellow discharges. Symphytum (Bone Knit) For broken bones once set by physician. Tabacum (Turning Green) Nausea and vomiting with dizziness, spinning, motion sickness; better for closing eyes. Vertigo with anxiety. Verat A (Purging) Vomiting and diarrhea at the same time with cold sweats and extreme exhaustion. Have to decide which end to put on the potty first. For flu, food poisoning or bad water."
},
{
"NDCCode": "0009-5181-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (0009-5181-01) / .5 mL in 1 SYRINGE (0009-5181-10) ",
"NDC11Code": "00009-5181-01",
"ProductNDC": "0009-5181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caverject Impulse",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVERNOUS",
"StartMarketingDate": "20020611",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021212",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "10",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020611",
"SamplePackage": "N",
"IndicationAndUsage": "CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1), 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).",
"Description": "CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water. The structural formula of alprostadil is represented below. CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration. 10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. 20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization."
},
{
"NDCCode": "0009-5182-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (0009-5182-01) / .5 mL in 1 SYRINGE (0009-5182-11) ",
"NDC11Code": "00009-5182-01",
"ProductNDC": "0009-5182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caverject Impulse",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVERNOUS",
"StartMarketingDate": "20020611",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021212",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "20",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020611",
"SamplePackage": "N",
"IndicationAndUsage": "CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1), 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).",
"Description": "CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water. The structural formula of alprostadil is represented below. CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration. 10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. 20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization."
},
{
"NDCCode": "0093-3002-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-3002-56) ",
"NDC11Code": "00093-3002-56",
"ProductNDC": "0093-3002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinine Sulfate",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091661",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120928",
"SamplePackage": "N",
"IndicationAndUsage": "Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use:Quinine sulfate capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "Quinine sulfate, USP is a cinchona alkaloid chemically described as bis[(R)-(6-methoxyquinolin-4-yl)-[2S,4S,5R)-5-ethenyl-1-azabicyclo[2.2.2]oct-2-yl]methanol] sulfate. The structural formula of quinine sulfate, USP is. C40H50N4O8S2H2O M.W. 783.0. Quinine sulfate, USP occurs as a white or almost white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is slightly soluble in water, sparingly soluble in boiling water and in alcohol, and practically insoluble in ether. Quinine Sulfate Capsules USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate, USP equivalent to 269 mg free base. Inactive ingredients: colloidal silicon dioxide, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. FDA approved dissolution test specifications differ from USP."
}
]
}
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<NDCList>
<NDC>
<NDCCode>59985-324-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-324-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0324-32</NDC11Code>
<ProductNDC>59985-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Mineral Absorption</ProprietaryNameSuffix>
<NonProprietaryName>Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Calcarea Sulphurica, Cuprum Metallicum, Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Iodium Purum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Sulphuricum, Selenium Metallicum, Silicea</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; COPPER; DIBASIC POTASSIUM PHOSPHATE; FERRIC PHOSPHATE; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SELENIUM; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Iron [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Facilitate the use of 16 minerals from your food and expensive supplements to maximize your investment. Minimizes leg cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42571-324-11</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (42571-324-11) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (42571-324-32) </PackageDescription>
<NDC11Code>42571-0324-11</NDC11Code>
<ProductNDC>42571-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211745</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69230-324-32</NDCCode>
<PackageDescription>7 PACKET in 1 CARTON (69230-324-32) / 17 g in 1 PACKET</PackageDescription>
<NDC11Code>69230-0324-32</NDC11Code>
<ProductNDC>69230-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214990</ApplicationNumber>
<LabelerName>Camber Consumer Care Inc</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-300-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-300-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0300-32</NDC11Code>
<ProductNDC>59985-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Allergy Mold, Dust And Hay</ProprietaryNameSuffix>
<NonProprietaryName>Bovista Lycoperdon, Secale Cornutum, Ustilago Maydis, Wyethia Helenioides</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CLAVICEPS PURPUREA SCLEROTIUM; LYCOPERDON UTRIFORME FRUITING BODY; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT</SubstanceName>
<StrengthNumber>6; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mold, dust & hay spritz helpful for relief of allergy symptoms - sneezing, itching, dullness, stuffy head, runny eyes & sinuses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-301-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-301-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0301-32</NDC11Code>
<ProductNDC>59985-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Anti-septic Cuts And Scrapes</ProprietaryNameSuffix>
<NonProprietaryName>Baptisia Tinctoria, Echinacea Purpurea, Nitricum Acidum, Thuja Occidentalis, Calendula Officinalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA WHOLE; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6; 30; 30; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Speed healing of cuts, scrapes and pain. Diminishes scars. Contains a natural antiseptic.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-305-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-305-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0305-32</NDC11Code>
<ProductNDC>59985-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Burn Relief</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria, Utrica Urens</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA; URTICA URENS WHOLE</SubstanceName>
<StrengthNumber>30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-310-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-310-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0310-32</NDC11Code>
<ProductNDC>59985-310</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Irritable Eye Relief</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Oxide, Amylenum Nitrosum, Argentum Nitricum, Arsenicum Iodatum, Calendula Officinalis, Conium Maculatum, Euphrasia Officinalis, Physostigma Venenosum, Ruta Graveolens</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ALUMINUM OXIDE; AMYL NITRITE; ARSENIC TRIIODIDE; CALENDULA OFFICINALIS FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE</SubstanceName>
<StrengthNumber>6; 6; 6; 30; 6; 6; 6; 30; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diminishes red, irritated, itchy dry eyes, discharge, eye fatigue, reading and computer strain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-315-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-315-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0315-32</NDC11Code>
<ProductNDC>59985-315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Sunburn Relief</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis, Capsicum Annuum, Cantharis Vesicatoria</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA</SubstanceName>
<StrengthNumber>30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use orally and or topically for scarring, pain, blistering. Reduces peeling. FAST RELIEF!.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-322-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-322-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0322-32</NDC11Code>
<ProductNDC>59985-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Antihistamine Action</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifica, Ledum Palustre, Vespa Crabro, Histamine, Cresolum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>APIS MELLIFERA; CRESOL; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For red, hot, stinging, intense, itching allergy symptoms including bites, punctures, and hives.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-323-32</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (59985-323-32) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59985-0323-32</NDC11Code>
<ProductNDC>59985-323</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Diminish Gluten Reactivity</ProprietaryNameSuffix>
<NonProprietaryName>Anatherum Muricatum, Avena Sativa, Arsenicum Album, Berberis Vulgaris, Dioscorea Villosa, Okoubaka Aubrevillei</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CHRYSOPOGON ZIZANIOIDES ROOT; DIOSCOREA VILLOSA TUBER; OKOUBAKA AUBREVILLEI BARK</SubstanceName>
<StrengthNumber>30; 30; 6; 30; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves the symptoms of abdominal pain, discomfort, gas and bloating following consumption of gluten and grains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0338-0341-04</NDCCode>
<PackageDescription>14 BAG in 1 CARTON (0338-0341-04) / 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-0341-04</NDC11Code>
<ProductNDC>0338-0341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardioplegic</ProprietaryName>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL</RouteName>
<StartMarketingDate>20000421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075323</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>17.6; 325.3; 119.3; 643</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.</IndicationAndUsage>
<Description>Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg and Sodium Chloride USP 643 mg in Water for Injection, USP. May contain HCl and/or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; Magnesium (Mg++) 32 mEq; Potassium (K+) 16 mEq; Sodium (Na+) 110 mEq; Chloride (Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl- 160 mEq and bicarbonate (HCO3-) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>0409-2012-32</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03) </PackageDescription>
<NDC11Code>00409-2012-32</NDC11Code>
<ProductNDC>0409-2012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Hydrochloride</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20050614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074137</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including buprenorphine hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Buprenorphine hydrochloride is a partial opioid agonist. The chemical name of buprenorphine hydrochloride is 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy 18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol, hydrochloride [5α, 7α(S)]. Buprenorphine hydrochloride is a white powder, weakly acidic and with limited solubility in water. Buprenorphine hydrochloride injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration. Each mL of buprenorphine hydrochloride injection contains 0.324 mg buprenorphine hydrochloride (equivalent to 0.3 mg buprenorphine), 50 mg anhydrous dextrose, water for injection and HCl to adjust pH to 3.5 to 5.5. Buprenorphine hydrochloride has the molecular formula, C29H41NO4∙HCl and the molecular weight of 504.09. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0409-7969-05</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-7969-05) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-7969-11) </PackageDescription>
<NDC11Code>00409-7969-05</NDC11Code>
<ProductNDC>0409-7969</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plegisol</ProprietaryName>
<NonProprietaryName>Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL</RouteName>
<StartMarketingDate>20050728</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018608</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>119.3; 643; 17.6; 325.3</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.</IndicationAndUsage>
<Description>Plegisol (Cardioplegic Solution) is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. It is a "core solution" intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; magnesium (Mg++) 32 mEq; potassium (K+) 16 mEq; sodium (Na+) 110 mEq; chloride (Cl‾) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH's of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl‾ 160 mEq and bicarbonate (HCO3‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Plegisol with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>24478-324-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24478-324-06) / 180 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>24478-0324-06</NDC11Code>
<ProductNDC>24478-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quillivant</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202100</ApplicationNumber>
<LabelerName>NextWave Pharmaceuticals, Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>mg/180mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Limitations of Use. The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>QUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80% extended-release methylphenidate. After reconstitution, QUILLIVANT XR contains in each 1 mL the equivalent of 5 mg of methylphenidate hydrochloride, present as methylphenidate (4.32 mg) complexed with sodium polystyrene sulfonate. Methylphenidate HCl is a central nervous system (CNS) stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is shown in Figure 1. Figure 1: Methylphenidate structure. C14H19NO2 Mol. Wt. 233.31. QUILLIVANT XR also contains the following inactive ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-469-35</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) </PackageDescription>
<NDC11Code>65162-0469-35</NDC11Code>
<ProductNDC>65162-469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eluryng</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>RING</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20191216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ETONOGESTREL; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>.12; .015</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR VAGINAL USE ONLY. EluRyng is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
<Description>EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent to translucent , colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol, USP (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, USP over a three-week period of use. EluRyng is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, USP. EluRyng is not made with natural rubber latex. EluRyng has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol, USP are 324.5 and 296.40, respectively. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>65219-258-10</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (65219-258-10) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (65219-258-01) </PackageDescription>
<NDC11Code>65219-0258-10</NDC11Code>
<ProductNDC>65219-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardioplegic Solution</ProprietaryName>
<NonProprietaryName>Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL</RouteName>
<StartMarketingDate>20220606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214623</ApplicationNumber>
<LabelerName>Fresenius Kabi, USA, LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>119.3; 643; 17.6; 325.3</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.</IndicationAndUsage>
<Description>Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. It is a "core solution" intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE). Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; magnesium (Mg++) 32 mEq; potassium (K+) 16 mEq; sodium (Na+) 110 mEq; chloride (Cl‾) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH's of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl‾ 160 mEq and bicarbonate (HCO3‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 6 H2O), deliquescent flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>68084-947-32</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-947-32) / 1 CAPSULE in 1 BLISTER PACK (68084-947-33) </PackageDescription>
<NDC11Code>68084-0947-32</NDC11Code>
<ProductNDC>68084-947</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinine Sulfate</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151130</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151207</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use: Quinine sulfate oral capsules are not approved for: : 1 Treatment of severe or complicated P. falciparum malaria. , 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)]. .</IndicationAndUsage>
<Description>Quinine sulfate capsules are a cinchona alkaloid chemically described as cinchonan-9-ol, 6’-methoxy-,(8α,9R)-,sulfate (2:1) (salt), dihydrate with a molecular formula of (C 20H 24N 2O 2) 2H 2SO 42H 2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>59985-101-11</NDCCode>
<PackageDescription>28.35 g in 1 JAR (59985-101-11) </PackageDescription>
<NDC11Code>59985-0101-11</NDC11Code>
<ProductNDC>59985-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Turbo Arnica</ProprietaryName>
<ProprietaryNameSuffix>Cream</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana Hpus</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARNICA MONTANA WHOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/28.35g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Used for injuries, sprains, sore muscles.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-103-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-103-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0103-12</NDC11Code>
<ProductNDC>59985-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Bug Bite Cream</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifica, Ledum Palustre, Histamine, Vespa Crabro, Calendula Officinalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>APIS MELLIFERA; CALENDULA OFFICINALIS FLOWERING TOP; HISTAMINE; RHODODENDRON AUREUM LEAF; VESPA CRABRO</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For bites, stings, hives, diminishing swelling, pain and itching from bees, wasps, and mosquitoes. KIDS FAVORITE!.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-105-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-105-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0105-12</NDC11Code>
<ProductNDC>59985-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Calendula Cream</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Speed healing of wounds, sores, acne sores and lips. Reduces scarring.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-108-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-108-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0108-12</NDC11Code>
<ProductNDC>59985-108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Blistering Relief Cream</ProprietaryNameSuffix>
<NonProprietaryName>Cantharis Vesicatoria, Chocolate, Calendula Officinalis, Natrum Muriaticum, Echinacea Angustifolia</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; COCOA; ECHINACEA ANGUSTIFOLIA WHOLE; LYTTA VESICATORIA; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For pain relief and accelerated healing of all blistering outbreaks around mouth and on lips/genitals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-109-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-109-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0109-12</NDC11Code>
<ProductNDC>59985-109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Irritable Skin Cream</ProprietaryNameSuffix>
<NonProprietaryName>Calcarea Sulphurica, Calendula Officinalis, Graphites Naturalis, Nux Vomica, Cresolum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>CALCIUM SULFATE ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; CRESOL; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>30; 30; 6; 30; 6; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relief for dry, cracking, miserable skin ailments. Use to facilitate healing of psoriasis and eczema.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-113-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-113-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0113-12</NDC11Code>
<ProductNDC>59985-113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Spider Bite Cream</ProprietaryNameSuffix>
<NonProprietaryName>Carbo Animalis, Alcoholus, Loxosceles Reclusa, Lachesis Mutus, Hamamelis Virginiana, Calendula Officinalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ALCOHOL; CALENDULA OFFICINALIS FLOWERING TOP; CARBO ANIMALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LOXOSCELES RECLUSA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 12; 6</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This remedy has affinity for minimizing the poisoning effect and diminishing the potential tissue damage allowing the wound to heal.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-114-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-114-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0114-12</NDC11Code>
<ProductNDC>59985-114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Sports Injury Cream</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Staphysagria, Calcarea Phosphorica</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM WHOLE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</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>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To diminish pain and inflammation of muscle, tendon, ligament, puncture wounds and bone injuries, including surgery, P.T., sports injuries and dentistry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-118-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (59985-118-12) / 28 g in 1 JAR</PackageDescription>
<NDC11Code>59985-0118-12</NDC11Code>
<ProductNDC>59985-118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Remedi Health Solutions</ProprietaryName>
<ProprietaryNameSuffix>Arnica Cream</ProprietaryNameSuffix>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ARNICA MONTANA WHOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/28g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Higher potency, significantly faster acting than most creams on the market. For sore muscles, sprains, bruising & injuries. (Use Calendula on. open sores.).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-217-22</NDCCode>
<PackageDescription>100 PELLET in 1 DRUM (59985-217-22) </PackageDescription>
<NDC11Code>59985-0217-22</NDC11Code>
<ProductNDC>59985-217</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Turbo Travel Sickness</ProprietaryName>
<ProprietaryNameSuffix>Relief</ProprietaryNameSuffix>
<NonProprietaryName>Tabacum, Hpus,cocculus, Hpus,ipecacuanha, Hpus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>IPECAC; JATEORHIZA CALUMBA ROOT; TOBACCO LEAF</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alleviate symptoms of travel sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59985-611-61</NDCCode>
<PackageDescription>46 VIAL, GLASS in 1 CASE (59985-611-61) / 100 PELLET in 1 VIAL, GLASS (59985-611-20) </PackageDescription>
<NDC11Code>59985-0611-61</NDC11Code>
<ProductNDC>59985-611</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family I</ProprietaryName>
<ProprietaryNameSuffix>Kit</ProprietaryNameSuffix>
<NonProprietaryName>30c Homeopathic Kit</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151230</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Chc Montana</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; ACTIVATED CHARCOAL; ALUMINUM OXIDE; ANAMIRTA COCCULUS SEED; ANTIMONY POTASSIUM TARTRATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA WHOLE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; DROSERA ROTUNDIFOLIA WHOLE; EUPHRASIA STRICTA; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM WHOLE; IPECAC; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA WHOLE; MERCURIC CHLORIDE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; RANCID BEEF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[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_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_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], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aconite (Fright) First remedy used for a cold when exposed to cold weather or wind. Like fear of flying, fear following a frightful event or shock. Alumina (Dryness) Dryness of stool, skin, mouth, eyes, vagina, etc. Ant Crud (Skin Cracks and Roughness) Roughness and cracks in nose and mouth, excessive appetite, warts, nausea, vomiting from overeating, sunstroke. Ant Tart (Rattling Chest) Cold, flu, elderly, small children, birthing. Cough remaining following the flu, blue babies, pneumonia-like symptoms. Apis (Bees) Red, hot, puffy, swollen, kidney edema. Feels like stinging pain; very tender and intolerant of heat, (sunburn, minor allergic reactions). Has an antihistamine action. Arg Nit (Exploding) Headache, anxiety, sugar cravings, especially chocolate. Constant throat clearing. Always in a hurry, insomnia with thoughts stuck over and over in head. Gas and bloating pressure. Arnica (Bruised) Accidental blows, sprains, bruised feeling, overwork of muscles, head injury, strokes. Also in cream. For broken skin, use orally and go to calendula cream as an antiseptic topically. Arsenicum (Poisoning) Vomiting, diarrhea as if had eaten rotten food. Burning pains with restlessness, worse at midnight. Dislike being alone. When ill, say “I feel like I’m going to die.”. Belladonna (Violent) Red, hot, throbbing. So violent in nature you need to transport to hospital. Give remedy during transport. High Fevers, pain of horrible things like migraines and appendicitis. Bryonia (Worsened by any movement) Back pain, migraine-worse even for eye movement. Patient says “Don’t touch me!”. Calendula This flower, as a remedy, is VERY FAST acting. Healing of internal and external ulcerations. Used to wash wounds and promote accelerated healing. Available as pellets, cream and tonic. Cantharis (Burns) Burning on skin, burning urination, great for sunburns too. Take orally and apply Calendula to skin. Spritz available. Carbo Veg (Reviver) Cold, clammy, gasping for air, needs to be fanned, runs to open window to breathe. General indigestion from milk or fatty foods. Faint and cold. Also, cleanse for fumes. Chamomilla (Angry Fits) Irritable “as if” too much coffee, cranky like teething baby. Nothing pleases them during anger. Wants something and then pushes it away. Over sensitive to pain. Baby colic of angry mother! Ear infections and childhood ailments. China O (Malaria) Debility from loss of fluids like heavy menses, prolonged diarrhea, fever with sweats and chills, giving blood. Returns vitality. It is also useful in ringing of the ear and faintness. Cocculus (Nurses Remedy) Debility and sleeplessness from caring for others, especially relatives. Sleeplessness, rolling over in bed, jet lag. Dizziness and car sickness, as if drunk. Coffea Cruda (Jittery) “As if” too much caffeine. Sleeplessness from being over excited like kids at Christmas or day before vacation. If jittery literally from caffeine, take Nux Vomica or Chamomilla. Colocynthis (Colic) Better for bending double (babies draw knees up). Cramp like abdominal pains, vomiting, relieved by applying pressure and leaning forward. Gall bladder-like symptoms. Drosera (Cough until you gag!) Whooping cough. Spasms or cough so hard it can induce vomiting sticky mucus. Feels trapped. Euphrasia (Eyebrite) Great for eye redness (pink eye), hay fever, and allergies. Ferr Phos (Iron) First remedy for fever of unknown origin, bloody nosed, heavy periods, tiredness from iron-poor blood.*If fevers don’t respond, go to Aconite or Belladonna. Gelsemium (Yellow) First remedy for flu with yellow discharge, nervous, weak, shivering, restless with frequent urination. Performance anxiety with frequent urination or diarrhea proceeding. DT’s (withdrawals). Hepar Sulph (Infections) Green, thick mucus of children, ear infection start in left and go to right, sore throat as if a splinter, boils, acne, etc. Histaminum General itchy allergies of eyes and skin, general inflammations and hives. Hypericum (Nerve Pain) Pain of a smashed finger (like in a door!); shooting pains, pains of dental work. Ignatia (Hysterical) Helpful for funerals and grief from unexpected events. Ailments from disappointments in love and circumstances. Helps to think clearly. Ipecacuaha (Nausea) Sick feeling not relieved by vomiting. May appear with other symptoms of flu or pregnancy. Also, great for flu with cough. Kali Bi First remedy for sinus infection with sticky stingy discharge. Headache between brows. Ledum (Homeopathic Tetanus) Pain and infection of puncture wounds. Punctures include insect bites! (Wounds may feel cold and pain is relieved by cold.) Never well since puncture like allergy shots, diabetes pricking frequently. Tetanus nosode also available. Lycopodium (Bullied or the bully) Milk aggravates digestion. Patient avoids beans and cabbage family vegetables to diminish embarrassment of gas and bloating. Flatulence worse between 4-8 pm. Great remedy for hernia. Mag Phos (Cramps and Bleeding) General cramps and spasms of menses, leg and feet, better with heading pad, bath or massage. Bloody noses. Mercury (infections) Abscesses in bone and nails, teeth infected, strep-throats, wetness, sweat or drool always present – profuse salvation. Sensitive to heat and cold, like a thermometer. Nat Mur Indicated for coughing on attempting to speak. Good menopausal remedy. (See Ars and Alum or vaginally dry.). Nux Vomica (Business men’s remedy) Not limited to males. Pain as if hangover, overworked, rushed, perfectionism, eating poorly. Excessive coffee, fast food, demanding, cranky and all the ailments of the 20th Century lifestyle; heartburn, hemorrhoids, cranky indigestion results. Phosphorus (Cough) Rare symptoms when ill. Cold that quickly goes to the chest. Bloody discharges, bloody noses. Hoarseness, dry, hard cough with fever, develops quickly from a cold setting in the chest. Patient craves cold drinks. People who love attention!. Pulsatilla(Common Child’s Remedy) Ailments of children who are comforted being held. Changeable symptoms with weariness. Better in fresh air. Sick from rich and fried foods. Needy girls. Good PMS remedy. Need to be in a group, yielding personality. Pyrogenium (Sepsis) Infections that look scary- high fever with rapid pulse- poisoning. When other infection remedies not effective. Any discharges with odor of rotting meat (abscess, sinus infections, etc.). Rhus Tox (Tin Man) Achy joints worse in storms or drop in barometer. Itchy skin eruptions; better bathing and better heat (when worse bathing, see Sulfur). Ruta (Tendon Injuries) Soreness of tendons from injury or overuse. Tired eyes from reading or computer work. Carpel tunnel syndrome. Silicea (Removes Foreign Bodies) For splinters under fingernails, to remove dirt from a wound, promote suppuration of abscess. Silicea will surround foreign body with fluid and bring to the surface. Thin hair and nails – defective nutritional assimilation. Spongia Tosta (Coughs) Worse wind-dry barking cough, cough better with warm drinks, cardiac cough. Hoarseness, dry, burning constriction feeling. Staphysagria The most indicated remedy after surgery to heal the incision and diminish chance of infection. Burning urination following new partner. (Honeymoon cystitis). Infection from others. Sulfur (Skin Remedy) Dry skin eruptions, worse with heat of bed or shower. Hot flashes, sinus infections, yellow discharges. Symphytum (Bone Knit) For broken bones once set by physician. Tabacum (Turning Green) Nausea and vomiting with dizziness, spinning, motion sickness; better for closing eyes. Vertigo with anxiety. Verat A (Purging) Vomiting and diarrhea at the same time with cold sweats and extreme exhaustion. Have to decide which end to put on the potty first. For flu, food poisoning or bad water.</IndicationAndUsage>
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<Description>CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water. The structural formula of alprostadil is represented below. CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration. 10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. 20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.</Description>
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<StartMarketingDate>20120928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
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<IndicationAndUsage>Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use:Quinine sulfate capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Quinine sulfate, USP is a cinchona alkaloid chemically described as bis[(R)-(6-methoxyquinolin-4-yl)-[2S,4S,5R)-5-ethenyl-1-azabicyclo[2.2.2]oct-2-yl]methanol] sulfate. The structural formula of quinine sulfate, USP is. C40H50N4O8S2H2O M.W. 783.0. Quinine sulfate, USP occurs as a white or almost white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is slightly soluble in water, sparingly soluble in boiling water and in alcohol, and practically insoluble in ether. Quinine Sulfate Capsules USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate, USP equivalent to 269 mg free base. Inactive ingredients: colloidal silicon dioxide, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. FDA approved dissolution test specifications differ from USP.</Description>
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