{
"NDC": [
{
"NDCCode": "57955-5015-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-5015-2)",
"NDC11Code": "57955-5015-02",
"ProductNDC": "57955-5015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Attention And Learning Enhancement",
"NonProprietaryName": "Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum And Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses naturally aids slow or difficult comprehension, overexcitement, writing wrong words or syllables, oversensitivity, forgetfulness, lack of assertiveness, shyness, and apprehension. Helps with both mental and physical development. Reference image attention.jpg."
},
{
"NDCCode": "10875-5015-2",
"PackageDescription": "181.44 kg in 1 DRUM (10875-5015-2) ",
"NDC11Code": "10875-5015-02",
"ProductNDC": "10875-5015",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Calumet Karns City Refining LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "26-JUN-14"
},
{
"NDCCode": "54868-5015-2",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (54868-5015-2)",
"NDC11Code": "54868-5015-02",
"ProductNDC": "54868-5015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040353",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Spironolactone tablets are indicated in the management of. Primary Hyperaldosteronism for. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous Conditions for Patients with. Congestive Heart Failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone tablets are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Cirrhosis of the Liver Accompanied by Edema and/or Ascites: Spironolactone levels may be exceptionally high in this condition. Spironolactone tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. Nephrotic Syndrome: For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.",
"Description": "Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α - mercapto-3-oxo-17α -pregn-4-ene-21-carboxylic acid (-lactone acetate. The molecular formula is C24H3204S and is represented by the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, crospovidone, dextrose, hypromellose, magnesium stearate, maltodextrin, natural peppermint flavor, polydextrose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide, triacetin."
},
{
"NDCCode": "63083-5015-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-5015-2) ",
"NDC11Code": "63083-5015-02",
"ProductNDC": "63083-5015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Muscle/ligament/cartilage Drops",
"ProprietaryNameSuffix": "5015",
"NonProprietaryName": "Muscle/ligament/cartilage Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "GLUCOSAMINE SULFATE; LEVOCARNITINE; ORNITHINE; BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE); CHONDROITIN SULFATE (BOVINE); MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; BOS TAURUS LIGAMENT",
"StrengthNumber": "3; 3; 3; 5; 6; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "67225-5015-2",
"PackageDescription": "2 CASE in 1 PACKAGE (67225-5015-2) / 14 g in 1 CASE",
"NDC11Code": "67225-5015-02",
"ProductNDC": "67225-5015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Age20s Signature Essence Pact Intense Cover 17n",
"NonProprietaryName": "Octinoxate, Octocrylene, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Aekyung Industrial Co., Ltd.",
"SubstanceName": "OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".42; .91; .7168",
"StrengthUnit": "g/14g; g/14g; g/14g",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "68210-5015-2",
"PackageDescription": "1 KIT in 1 CARTON (68210-5015-2) * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "68210-5015-02",
"ProductNDC": "68210-5015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Non Drows Cold And Flu And Nighttime Cold And",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20230526",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Spirit Pharmaceuticals LLC",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230526",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 fever, 2 headache, 3 minor aches and pain, 4 cough due to minor throat and bronchial iffitation, 5 sore throat, 6 nasal congestion (Daytime only), 7 runny nose and sneezing (Nighttime only)."
},
{
"NDCCode": "0074-5015-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00074-5015-01",
"ProductNDC": "0074-5015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skyrizi",
"NonProprietaryName": "Risankizumab-rzaa",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761262",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "RISANKIZUMAB",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).",
"Description": "Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7."
},
{
"NDCCode": "0074-5015-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-02) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00074-5015-02",
"ProductNDC": "0074-5015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skyrizi",
"NonProprietaryName": "Risankizumab-rzaa",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761262",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "RISANKIZUMAB",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "Y",
"IndicationAndUsage": "SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).",
"Description": "Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7."
},
{
"NDCCode": "57955-0001-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0001-2)",
"NDC11Code": "57955-0001-02",
"ProductNDC": "57955-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eating Disorders",
"NonProprietaryName": "Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc",
"SubstanceName": "ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders."
},
{
"NDCCode": "57955-0002-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0002-2)",
"NDC11Code": "57955-0002-02",
"ProductNDC": "57955-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Birth Ease",
"NonProprietaryName": "Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache."
},
{
"NDCCode": "57955-0003-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0003-2)",
"NDC11Code": "57955-0003-02",
"ProductNDC": "57955-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Breast Cyst And Discomforts",
"NonProprietaryName": "Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing."
},
{
"NDCCode": "57955-0004-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0004-2)",
"NDC11Code": "57955-0004-02",
"ProductNDC": "57955-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menstrual Cramps And Irregularities",
"NonProprietaryName": "Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow."
},
{
"NDCCode": "57955-0005-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0005-2)",
"NDC11Code": "57955-0005-02",
"ProductNDC": "57955-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferticare",
"NonProprietaryName": "Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse."
},
{
"NDCCode": "57955-0008-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0008-2)",
"NDC11Code": "57955-0008-02",
"ProductNDC": "57955-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Morning Sickness",
"NonProprietaryName": "Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity."
},
{
"NDCCode": "57955-0010-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0010-2)",
"NDC11Code": "57955-0010-02",
"ProductNDC": "57955-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Strengthener",
"NonProprietaryName": "Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140421",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness ."
},
{
"NDCCode": "57955-0011-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0011-2)",
"NDC11Code": "57955-0011-02",
"ProductNDC": "57955-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prostate Strengthener",
"NonProprietaryName": "Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence."
},
{
"NDCCode": "57955-0012-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0012-2)",
"NDC11Code": "57955-0012-02",
"ProductNDC": "57955-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bed Wetting Prevention",
"NonProprietaryName": "Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep.."
},
{
"NDCCode": "57955-0015-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0015-2)",
"NDC11Code": "57955-0015-02",
"ProductNDC": "57955-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Attention And Learning Enhancement",
"NonProprietaryName": "Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140528",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57955-0016-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0016-2)",
"NDC11Code": "57955-0016-02",
"ProductNDC": "57955-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Paraclenz",
"NonProprietaryName": "Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods."
},
{
"NDCCode": "57955-0017-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0017-2)",
"NDC11Code": "57955-0017-02",
"ProductNDC": "57955-0017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tonsilcure",
"NonProprietaryName": "Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous."
},
{
"NDCCode": "57955-0018-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0018-2)",
"NDC11Code": "57955-0018-02",
"ProductNDC": "57955-0018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teething",
"NonProprietaryName": "Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly."
},
{
"NDCCode": "57955-0019-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0019-2)",
"NDC11Code": "57955-0019-02",
"ProductNDC": "57955-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation Relief",
"NonProprietaryName": "Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160627",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache."
},
{
"NDCCode": "57955-0020-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0020-2)",
"NDC11Code": "57955-0020-02",
"ProductNDC": "57955-0020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea Relief",
"NonProprietaryName": "Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of diarrhea: loose and watery stools, cramps, gas and bloating, mucus in stools, jelly-like stool, sudden evacuation, intestinal gurgling, involuntary stools, diarrhea caused by certain foods or emotional excitement."
},
{
"NDCCode": "57955-0021-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0021-2)",
"NDC11Code": "57955-0021-02",
"ProductNDC": "57955-0021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gout Symptom Relief",
"NonProprietaryName": "Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains."
},
{
"NDCCode": "57955-0022-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0022-2)",
"NDC11Code": "57955-0022-02",
"ProductNDC": "57955-0022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburn Relief",
"NonProprietaryName": "Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic relief of: acid reflux, burning pain, sour stomach, belching, indigestion, nausea, stomach spasms, stomach distention."
},
{
"NDCCode": "57955-0023-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0023-2)",
"NDC11Code": "57955-0023-02",
"ProductNDC": "57955-0023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoid Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140604",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of hemorrhoid symptoms: rectal itching, backache, burning, aching or splintering pain."
},
{
"NDCCode": "57955-0024-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0024-2)",
"NDC11Code": "57955-0024-02",
"ProductNDC": "57955-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indigestion Relief",
"NonProprietaryName": "Antimonium Crudum, Argentum Nitricum, Carbo Vegetabilis, Chelidonium Majus, Cinchona Officinalis, Graphites, Hydrastis Canadensis, Ipecacuanha, Kali Carbonicum, Lycopodium Clavatum, Nux Vomica, Pulsatilla",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121023",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms following food or drink consumption: gas, bloating, belching, intestinal distress, hiccups, flatulence, nausea, vomiting, sleepiness."
},
{
"NDCCode": "57955-0028-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0028-2)",
"NDC11Code": "57955-0028-02",
"ProductNDC": "57955-0028",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Migraine Freee",
"NonProprietaryName": "Gelsemium Sempervirens, Glonoinum, Iris Versicolor, Kali Carbonicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Secale Cornutum, Spigelia Anthelmia, Sulphur, Niccolum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150218",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SPIGELIA ANTHELMIA; SULFUR; NICKEL",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: migraine headaches, sick, throbbing, or occipital headache, nausea, sun or morning headaches."
},
{
"NDCCode": "57955-0031-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0031-2)",
"NDC11Code": "57955-0031-02",
"ProductNDC": "57955-0031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sporting Edge",
"NonProprietaryName": "Arnica Montana, Kali Carbonicum, Kali Phosphoricum, Lacticum Acidum, Natrum Phosphoricum, Quebracho, Rhus Toxicodendron, Sarcolacticum Acidum, Zincum Oxydatum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121023",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; ZINC OXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: muscle and joint soreness, aches, morning stiffness, bruises and tightness after sports participation, exercise, or exertion."
},
{
"NDCCode": "57955-0032-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0032-2)",
"NDC11Code": "57955-0032-02",
"ProductNDC": "57955-0032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tmj Jaw Formula",
"NonProprietaryName": "Baptisia Tinctoria, Calcarea Fluorica, Causticum, Hepar Sulphuris Calcareum, Hypericum Perforatum, Ignatia Amar, Kalmia Latifolia, Nux Vomica, Phytolacca Decandra, Rhus Toxicodendron, Sanguinaria Canadensis, Symphytum Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BAPTISIA TINCTORIA ROOT; CALCIUM FLUORIDE; CAUSTICUM; CALCIUM SULFIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; COMFREY ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: facial pains of the jaw, facial neuralgias, rigid jaw muscles, inflammation in the jaw, clenching of the jaw, cracking sounds."
}
]
}
{"NDC":[{"NDCCode":"57955-5015-2","ProprietaryName":"Attention And Learning Enhancement","NonProprietaryName":"Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum And Thuja Occidentalis"},{"NDCCode":"10875-5015-2","NonProprietaryName":"Mineral"},{"NDCCode":"54868-5015-2","ProprietaryName":"Spironolactone","NonProprietaryName":"Spironolactone"},{"NDCCode":"63083-5015-2","ProprietaryName":"Muscle/ligament/cartilage Drops","NonProprietaryName":"Muscle/ligament/cartilage Drops"},{"NDCCode":"67225-5015-2","ProprietaryName":"Age20s Signature Essence Pact Intense Cover 17n","NonProprietaryName":"Octinoxate, Octocrylene, Titanium Dioxide"},{"NDCCode":"68210-5015-2","ProprietaryName":"Daytime Non Drows Cold And Flu And Nighttime Cold And","NonProprietaryName":"Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride"},{"NDCCode":"0074-5015-01","ProprietaryName":"Skyrizi","NonProprietaryName":"Risankizumab-rzaa"},{"NDCCode":"0074-5015-02","ProprietaryName":"Skyrizi","NonProprietaryName":"Risankizumab-rzaa"},{"NDCCode":"57955-0001-2","ProprietaryName":"Eating Disorders","NonProprietaryName":"Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album"},{"NDCCode":"57955-0002-2","ProprietaryName":"Birth Ease","NonProprietaryName":"Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus"},{"NDCCode":"57955-0003-2","ProprietaryName":"Breast Cyst And Discomforts","NonProprietaryName":"Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea"},{"NDCCode":"57955-0004-2","ProprietaryName":"Menstrual Cramps And Irregularities","NonProprietaryName":"Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum"},{"NDCCode":"57955-0005-2","ProprietaryName":"Ferticare","NonProprietaryName":"Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia"},{"NDCCode":"57955-0008-2","ProprietaryName":"Morning Sickness","NonProprietaryName":"Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum"},{"NDCCode":"57955-0010-2","ProprietaryName":"Male Strengthener","NonProprietaryName":"Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum"},{"NDCCode":"57955-0011-2","ProprietaryName":"Prostate Strengthener","NonProprietaryName":"Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum"},{"NDCCode":"57955-0012-2","ProprietaryName":"Bed Wetting Prevention","NonProprietaryName":"Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia"},{"NDCCode":"57955-0015-2","ProprietaryName":"Attention And Learning Enhancement","NonProprietaryName":"Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis"},{"NDCCode":"57955-0016-2","ProprietaryName":"Paraclenz","NonProprietaryName":"Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale"},{"NDCCode":"57955-0017-2","ProprietaryName":"Tonsilcure","NonProprietaryName":"Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea"},{"NDCCode":"57955-0018-2","ProprietaryName":"Teething","NonProprietaryName":"Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum"},{"NDCCode":"57955-0019-2","ProprietaryName":"Constipation Relief","NonProprietaryName":"Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia"},{"NDCCode":"57955-0020-2","ProprietaryName":"Diarrhea Relief","NonProprietaryName":"Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album"},{"NDCCode":"57955-0021-2","ProprietaryName":"Gout Symptom Relief","NonProprietaryName":"Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens"},{"NDCCode":"57955-0022-2","ProprietaryName":"Heartburn Relief","NonProprietaryName":"Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum"},{"NDCCode":"57955-0023-2","ProprietaryName":"Hemorrhoid Relief","NonProprietaryName":"Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur"},{"NDCCode":"57955-0024-2","ProprietaryName":"Indigestion Relief","NonProprietaryName":"Antimonium Crudum, Argentum Nitricum, Carbo Vegetabilis, Chelidonium Majus, Cinchona Officinalis, Graphites, Hydrastis Canadensis, Ipecacuanha, Kali Carbonicum, Lycopodium Clavatum, Nux Vomica, Pulsatilla"},{"NDCCode":"57955-0028-2","ProprietaryName":"Migraine Freee","NonProprietaryName":"Gelsemium Sempervirens, Glonoinum, Iris Versicolor, Kali Carbonicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Secale Cornutum, Spigelia Anthelmia, Sulphur, Niccolum Metallicum"},{"NDCCode":"57955-0031-2","ProprietaryName":"Sporting Edge","NonProprietaryName":"Arnica Montana, Kali Carbonicum, Kali Phosphoricum, Lacticum Acidum, Natrum Phosphoricum, Quebracho, Rhus Toxicodendron, Sarcolacticum Acidum, Zincum Oxydatum"},{"NDCCode":"57955-0032-2","ProprietaryName":"Tmj Jaw Formula","NonProprietaryName":"Baptisia Tinctoria, Calcarea Fluorica, Causticum, Hepar Sulphuris Calcareum, Hypericum Perforatum, Ignatia Amar, Kalmia Latifolia, Nux Vomica, Phytolacca Decandra, Rhus Toxicodendron, Sanguinaria Canadensis, Symphytum Officinale"}]}
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<NDCList>
<NDC>
<NDCCode>57955-5015-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-5015-2)</PackageDescription>
<NDC11Code>57955-5015-02</NDC11Code>
<ProductNDC>57955-5015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Attention And Learning Enhancement</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum And Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111031</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses naturally aids slow or difficult comprehension, overexcitement, writing wrong words or syllables, oversensitivity, forgetfulness, lack of assertiveness, shyness, and apprehension. Helps with both mental and physical development. Reference image attention.jpg.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10875-5015-2</NDCCode>
<PackageDescription>181.44 kg in 1 DRUM (10875-5015-2) </PackageDescription>
<NDC11Code>10875-5015-02</NDC11Code>
<ProductNDC>10875-5015</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mineral</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140626</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Calumet Karns City Refining LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-JUN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>54868-5015-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (54868-5015-2)</PackageDescription>
<NDC11Code>54868-5015-02</NDC11Code>
<ProductNDC>54868-5015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040353</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Spironolactone tablets are indicated in the management of. Primary Hyperaldosteronism for. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous Conditions for Patients with. Congestive Heart Failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone tablets are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Cirrhosis of the Liver Accompanied by Edema and/or Ascites: Spironolactone levels may be exceptionally high in this condition. Spironolactone tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. Nephrotic Syndrome: For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.</IndicationAndUsage>
<Description>Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α - mercapto-3-oxo-17α -pregn-4-ene-21-carboxylic acid (-lactone acetate. The molecular formula is C24H3204S and is represented by the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, crospovidone, dextrose, hypromellose, magnesium stearate, maltodextrin, natural peppermint flavor, polydextrose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>63083-5015-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-5015-2) </PackageDescription>
<NDC11Code>63083-5015-02</NDC11Code>
<ProductNDC>63083-5015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Muscle/ligament/cartilage Drops</ProprietaryName>
<ProprietaryNameSuffix>5015</ProprietaryNameSuffix>
<NonProprietaryName>Muscle/ligament/cartilage Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>GLUCOSAMINE SULFATE; LEVOCARNITINE; ORNITHINE; BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE); CHONDROITIN SULFATE (BOVINE); MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; BOS TAURUS LIGAMENT</SubstanceName>
<StrengthNumber>3; 3; 3; 5; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67225-5015-2</NDCCode>
<PackageDescription>2 CASE in 1 PACKAGE (67225-5015-2) / 14 g in 1 CASE</PackageDescription>
<NDC11Code>67225-5015-02</NDC11Code>
<ProductNDC>67225-5015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Age20s Signature Essence Pact Intense Cover 17n</ProprietaryName>
<NonProprietaryName>Octinoxate, Octocrylene, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241011</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Aekyung Industrial Co., Ltd.</LabelerName>
<SubstanceName>OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.42; .91; .7168</StrengthNumber>
<StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68210-5015-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68210-5015-2) * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68210-5015-02</NDC11Code>
<ProductNDC>68210-5015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Non Drows Cold And Flu And Nighttime Cold And</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Spirit Pharmaceuticals LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 fever, 2 headache, 3 minor aches and pain, 4 cough due to minor throat and bronchial iffitation, 5 sore throat, 6 nasal congestion (Daytime only), 7 runny nose and sneezing (Nighttime only).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0074-5015-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00074-5015-01</NDC11Code>
<ProductNDC>0074-5015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skyrizi</ProprietaryName>
<NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761262</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>RISANKIZUMAB</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
<Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
</NDC>
<NDC>
<NDCCode>0074-5015-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0074-5015-02) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00074-5015-02</NDC11Code>
<ProductNDC>0074-5015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skyrizi</ProprietaryName>
<NonProprietaryName>Risankizumab-rzaa</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761262</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>RISANKIZUMAB</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: 1 moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. (1.1) , 2 active psoriatic arthritis in adults and pediatric patients 6 years of age and older. (1.2), 3 moderately to severely active Crohn's disease in adults. (1.3), 4 moderately to severely active ulcerative colitis in adults. (1.4).</IndicationAndUsage>
<Description>Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa. SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2. SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use. Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use. Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use. Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7. SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion. SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial. Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.</Description>
</NDC>
<NDC>
<NDCCode>57955-0001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0001-2)</PackageDescription>
<NDC11Code>57955-0001-02</NDC11Code>
<ProductNDC>57955-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eating Disorders</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0002-2)</PackageDescription>
<NDC11Code>57955-0002-02</NDC11Code>
<ProductNDC>57955-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Birth Ease</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0003-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0003-2)</PackageDescription>
<NDC11Code>57955-0003-02</NDC11Code>
<ProductNDC>57955-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Breast Cyst And Discomforts</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0004-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0004-2)</PackageDescription>
<NDC11Code>57955-0004-02</NDC11Code>
<ProductNDC>57955-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menstrual Cramps And Irregularities</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0005-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0005-2)</PackageDescription>
<NDC11Code>57955-0005-02</NDC11Code>
<ProductNDC>57955-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferticare</ProprietaryName>
<NonProprietaryName>Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0008-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0008-2)</PackageDescription>
<NDC11Code>57955-0008-02</NDC11Code>
<ProductNDC>57955-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Morning Sickness</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0010-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0010-2)</PackageDescription>
<NDC11Code>57955-0010-02</NDC11Code>
<ProductNDC>57955-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Strengthener</ProprietaryName>
<NonProprietaryName>Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140421</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0011-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0011-2)</PackageDescription>
<NDC11Code>57955-0011-02</NDC11Code>
<ProductNDC>57955-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prostate Strengthener</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140331</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0012-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0012-2)</PackageDescription>
<NDC11Code>57955-0012-02</NDC11Code>
<ProductNDC>57955-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bed Wetting Prevention</ProprietaryName>
<NonProprietaryName>Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep..</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0015-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0015-2)</PackageDescription>
<NDC11Code>57955-0015-02</NDC11Code>
<ProductNDC>57955-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Attention And Learning Enhancement</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140528</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57955-0016-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0016-2)</PackageDescription>
<NDC11Code>57955-0016-02</NDC11Code>
<ProductNDC>57955-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Paraclenz</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0017-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0017-2)</PackageDescription>
<NDC11Code>57955-0017-02</NDC11Code>
<ProductNDC>57955-0017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tonsilcure</ProprietaryName>
<NonProprietaryName>Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0018-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0018-2)</PackageDescription>
<NDC11Code>57955-0018-02</NDC11Code>
<ProductNDC>57955-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Teething</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0019-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0019-2)</PackageDescription>
<NDC11Code>57955-0019-02</NDC11Code>
<ProductNDC>57955-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation Relief</ProprietaryName>
<NonProprietaryName>Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160627</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0020-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0020-2)</PackageDescription>
<NDC11Code>57955-0020-02</NDC11Code>
<ProductNDC>57955-0020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea Relief</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of diarrhea: loose and watery stools, cramps, gas and bloating, mucus in stools, jelly-like stool, sudden evacuation, intestinal gurgling, involuntary stools, diarrhea caused by certain foods or emotional excitement.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0021-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0021-2)</PackageDescription>
<NDC11Code>57955-0021-02</NDC11Code>
<ProductNDC>57955-0021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gout Symptom Relief</ProprietaryName>
<NonProprietaryName>Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0022-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0022-2)</PackageDescription>
<NDC11Code>57955-0022-02</NDC11Code>
<ProductNDC>57955-0022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburn Relief</ProprietaryName>
<NonProprietaryName>Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic relief of: acid reflux, burning pain, sour stomach, belching, indigestion, nausea, stomach spasms, stomach distention.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0023-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0023-2)</PackageDescription>
<NDC11Code>57955-0023-02</NDC11Code>
<ProductNDC>57955-0023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hemorrhoid Relief</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Aloe Socotrina, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Nux Vomica, Paeonia Officinalis, Ratanhia, Sepia, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of hemorrhoid symptoms: rectal itching, backache, burning, aching or splintering pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0024-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0024-2)</PackageDescription>
<NDC11Code>57955-0024-02</NDC11Code>
<ProductNDC>57955-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Indigestion Relief</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Argentum Nitricum, Carbo Vegetabilis, Chelidonium Majus, Cinchona Officinalis, Graphites, Hydrastis Canadensis, Ipecacuanha, Kali Carbonicum, Lycopodium Clavatum, Nux Vomica, Pulsatilla</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121023</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms following food or drink consumption: gas, bloating, belching, intestinal distress, hiccups, flatulence, nausea, vomiting, sleepiness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0028-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0028-2)</PackageDescription>
<NDC11Code>57955-0028-02</NDC11Code>
<ProductNDC>57955-0028</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Migraine Freee</ProprietaryName>
<NonProprietaryName>Gelsemium Sempervirens, Glonoinum, Iris Versicolor, Kali Carbonicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Secale Cornutum, Spigelia Anthelmia, Sulphur, Niccolum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SPIGELIA ANTHELMIA; SULFUR; NICKEL</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: migraine headaches, sick, throbbing, or occipital headache, nausea, sun or morning headaches.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0031-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0031-2)</PackageDescription>
<NDC11Code>57955-0031-02</NDC11Code>
<ProductNDC>57955-0031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sporting Edge</ProprietaryName>
<NonProprietaryName>Arnica Montana, Kali Carbonicum, Kali Phosphoricum, Lacticum Acidum, Natrum Phosphoricum, Quebracho, Rhus Toxicodendron, Sarcolacticum Acidum, Zincum Oxydatum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121023</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; ZINC OXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: muscle and joint soreness, aches, morning stiffness, bruises and tightness after sports participation, exercise, or exertion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0032-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0032-2)</PackageDescription>
<NDC11Code>57955-0032-02</NDC11Code>
<ProductNDC>57955-0032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tmj Jaw Formula</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Calcarea Fluorica, Causticum, Hepar Sulphuris Calcareum, Hypericum Perforatum, Ignatia Amar, Kalmia Latifolia, Nux Vomica, Phytolacca Decandra, Rhus Toxicodendron, Sanguinaria Canadensis, Symphytum Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT; CALCIUM FLUORIDE; CAUSTICUM; CALCIUM SULFIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; COMFREY ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: facial pains of the jaw, facial neuralgias, rigid jaw muscles, inflammation in the jaw, clenching of the jaw, cracking sounds.</IndicationAndUsage>
</NDC>
</NDCList>