{
"NDC": [
{
"NDCCode": "57955-0919-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0919-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0919-03",
"ProductNDC": "57955-0919",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rosacea Symptom Relief",
"NonProprietaryName": "Calendula Officinalis, Cardiospermum, Chamomilla, Hydrocotyle Asiatica, Rhus Tox, Thuja Occidentalis",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; CENTELLA ASIATICA; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 2; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of multiple symptoms of rosacea: facial redness burning stinging allergic skin eruptions itching dermatitis pimples swelling thickening of skin. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "37662-0919-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0919-3) ",
"NDC11Code": "37662-0919-03",
"ProductNDC": "37662-0919",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lactuca Virosa",
"NonProprietaryName": "Lactuca Virosa",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220714",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "LACTUCA VIROSA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220714",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0919-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0919-3)",
"NDC11Code": "49288-0919-03",
"ProductNDC": "49288-0919",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Treatment Set Ts349631",
"NonProprietaryName": "Treatment Set Ts349631",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19861031",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN",
"StrengthNumber": ".0004; .002; .0004; .00008; 160; .002; .00008; .00008; .00008; .00008; .0004; .0004; .00008; .00004; .00004; .0004; .001; .001; .0004; .00008; .00008",
"StrengthUnit": "g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.",
"Description": "Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery."
},
{
"NDCCode": "50090-0919-3",
"PackageDescription": "120 TABLET in 1 BOTTLE (50090-0919-3) ",
"NDC11Code": "50090-0919-03",
"ProductNDC": "50090-0919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "325; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150714",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51552-0919-3",
"PackageDescription": "100 g in 1 CONTAINER (51552-0919-3)",
"NDC11Code": "51552-0919-03",
"ProductNDC": "51552-0919",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pentravan",
"DosageFormName": "CREAM",
"StartMarketingDate": "20120102",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "ISOPROPYL MYRISTATE; POLYOXYL 40 STEARATE; STEARYL ALCOHOL; CETYL ALCOHOL; GLYCERYL MONOSTEARATE; STEARIC ACID; UREA",
"StrengthNumber": "1; 1; 1; 1; 1; 1; 1",
"StrengthUnit": "g/g; g/g; g/g; g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "57955-0815-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0815-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0815-03",
"ProductNDC": "57955-0815",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mole Remover",
"NonProprietaryName": "Carbo Vegetabilis, Graphites, Lycopodium Clavatum, Phytolacca Decandra, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140813",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CARBO ANIMALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180112",
"SamplePackage": "N",
"IndicationAndUsage": "Uses † for symptomatic treatment of moles, birthmarks, brown spots, or freckles. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "57955-0816-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0816-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0816-03",
"ProductNDC": "57955-0816",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scar Remover",
"NonProprietaryName": "Arnica Montana, Calcarea Fluorica, Calcarea Phosphorica, Calendula Officinalis, Graphites, Hydrofluoricum Acidum, Phytolacca Decandra, Sabina, Silicea, Thiosinaminum, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140318",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; SILICON DIOXIDE; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of scar tissue."
},
{
"NDCCode": "57955-0817-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0817-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0817-03",
"ProductNDC": "57955-0817",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cherry Angioma Remover",
"NonProprietaryName": "Benzoicum Acidum, Calcarea Carbonica, Calcarea Iodata, Iodium, Phosphoricum Acidum, Phosphorus, Sulphuricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140805",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; IODINE; PHOSPHORIC ACID; PHOSPHORUS; SULFURIC ACID",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of red spots or blood boils associated with angiomas."
},
{
"NDCCode": "57955-0818-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0818-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-0818-03",
"ProductNDC": "57955-0818",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wart Remover",
"NonProprietaryName": "Antimonium Crudum, Causticum, Dulcamara, Kali Muriaticum, Nitricum Acidum, Sabina, Staphysagria, Sulfur, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140318",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; POTASSIUM CHLORIDE; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of smooth or rough warts and dry, itching or unhealthy skin. †as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "57955-0920-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0920-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0920-03",
"ProductNDC": "57955-0920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psoriasis Symptom Relief",
"NonProprietaryName": "Cardiospermum, Chamomilla, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Lappa Major, Phytolacca Decandra, Rumex Crispus, Ruta Graveolens, Taraxacum Officinale",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "2; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of multiple symptoms of psoriasis: itching rash redness thickening of skin exfoliation of scales and crusts allergic skin eruptions. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested."
},
{
"NDCCode": "57955-0921-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0921-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0921-03",
"ProductNDC": "57955-0921",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Symptom Relief",
"NonProprietaryName": "Cardiospermum, Hydrastis Canadensis, Hydrocotyle Asiatica, Lappa Major, Rhus Tox, Rumex Crispus, Ruta Graveolens, Sanguinaria Canadensis, Taraxacum Officinale",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CARDIOSPERMUM HALICACABUM FLOWERING TOP; GOLDENSEAL; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; TARAXACUM OFFICINALE",
"StrengthNumber": "2; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of eczema: redness intense itching allergic skin eruptions dry or moist eruptions thickened, crusty, scaly skin inflamed skin general unhealthy skin."
},
{
"NDCCode": "57955-0935-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-0935-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-0935-03",
"ProductNDC": "57955-0935",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warming Arthritic Pain And Joint Relief",
"NonProprietaryName": "Actaea Spicata, Aescuculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Pharm_Classes": "Mood Stabilizer [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of symptoms: minor aches & pains associated with arthitis, backache, leg cramps, stiff, swollen joints, physical weakness, sore tendons and ligaments, body aches, hip & knee discomforts, muscular soreness, restless limbs."
},
{
"NDCCode": "57955-3203-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-3203-3) > 73 g in 1 TUBE",
"NDC11Code": "57955-3203-03",
"ProductNDC": "57955-3203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Gel",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160307",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/73g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses Temporarily relieves: swelling form minor injuries muscle pain and stiffness, and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product \"Uses\" have not been evaluated by the FDA. Product has not been clinically tested."
},
{
"NDCCode": "57955-4000-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-4000-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-4000-03",
"ProductNDC": "57955-4000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothing Advanced Arnica",
"NonProprietaryName": "Arnica Montana, Arnica Montana, Radix",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120718",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; ARNICA MONTANA ROOT",
"StrengthNumber": "6; 6",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: 1 pain or stiffness in muscles or joints, 2 bruising and discoloration, 3 inflammation, 4 soreness after exercise."
},
{
"NDCCode": "57955-4001-3",
"PackageDescription": "1 TUBE in 1 CARTON (57955-4001-3) > 85 g in 1 TUBE",
"NDC11Code": "57955-4001-03",
"ProductNDC": "57955-4001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cooling Acute Pain Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180220",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180220",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints."
},
{
"NDCCode": "57955-7301-3",
"PackageDescription": "85 g in 1 TUBE (57955-7301-3)",
"NDC11Code": "57955-7301-03",
"ProductNDC": "57955-7301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothing Advanced Arnica",
"NonProprietaryName": "Arnica Montana, Arnica Montana, Radix",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARNICA MONTANA; ARNICA MONTANA ROOT",
"StrengthNumber": "6; 6",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: stiff muscles or joints inflammation bruising and discoloration. soreness after exercise."
},
{
"NDCCode": "57955-7302-3",
"PackageDescription": "85 g in 1 TUBE (57955-7302-3)",
"NDC11Code": "57955-7302-03",
"ProductNDC": "57955-7302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cooling Acute Pain Relief",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints."
},
{
"NDCCode": "57955-7800-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-7800-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-7800-03",
"ProductNDC": "57955-7800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Tag Remover",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130426",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas."
},
{
"NDCCode": "57955-8699-3",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-8699-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "57955-8699-03",
"ProductNDC": "57955-8699",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Tag Remover",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140108",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas."
},
{
"NDCCode": "10544-919-14",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10544-919-14)",
"NDC11Code": "10544-0919-14",
"ProductNDC": "10544-919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091549",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules, USP and other treatment options before deciding to use Indomethacin Extended-Release Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin Extended-Release Capsules, USP have been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to sever osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendonitis). Indomethacin Extended-Release Capsules, USP are not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more sever forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects. The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not product any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (see PRECAUTIONS, Drug Interactions).",
"Description": "Indomethacin cannot be considered a simple analgesic and should not be used in conditions other than those recommended under INDICATION AND USAGE. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The structural formula is:. M.W. 357.80 C 19H1 6ClNO 4. Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No. 3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "11344-919-65",
"PackageDescription": "30 PACKET in 1 POUCH (11344-919-65) > 3 mL in 1 PACKET",
"NDC11Code": "11344-0919-65",
"ProductNDC": "11344-919",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "19981113",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19981113",
"SamplePackage": "N"
},
{
"NDCCode": "11673-919-30",
"PackageDescription": "3 BOTTLE, DROPPER in 1 CARTON (11673-919-30) / 60 mL in 1 BOTTLE, DROPPER (11673-919-16) ",
"NDC11Code": "11673-0919-30",
"ProductNDC": "11673-919",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Hair Regrowth Treatment For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075357",
"LabelerName": "Target Corporation",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220105",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "11822-0919-0",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (11822-0919-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "11822-0919-00",
"ProductNDC": "11822-0919",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20200925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076011",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200925",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "16714-919-01",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-919-01) ",
"NDC11Code": "16714-0919-01",
"ProductNDC": "16714-919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206156",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "2.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190306",
"SamplePackage": "N",
"IndicationAndUsage": "Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.",
"Description": "Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride extended-release tablets, 0.375 mg. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 0.75 mg. Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 1.5 mg. Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 2.25 mg. Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 3 mg. Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 4.5 mg. Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride,USP. Inactive ingredients for all strengths of pramipexole dihydrochloride extended-release tablets consist of hypromellose, mannitol, pregelatinized starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "21695-919-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (21695-919-90)",
"NDC11Code": "21695-0919-90",
"ProductNDC": "21695-919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diovan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021283",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Diovan is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension (1.1), 2 Treatment of heart failure (NYHA class II-IV); Diovan significantly reduced hospitalization for heart failure (1.2), 3 Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction (1.3).",
"Description": "Diovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Diovan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide."
},
{
"NDCCode": "30142-919-56",
"PackageDescription": "226 g in 1 BOTTLE, PLASTIC (30142-919-56)",
"NDC11Code": "30142-0919-56",
"ProductNDC": "30142-919",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Sport Sunscreen",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THE KROGER CO",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 13; 5; 5; 6",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in the water."
},
{
"NDCCode": "31722-919-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-919-01) ",
"NDC11Code": "31722-0919-01",
"ProductNDC": "31722-919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170808",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see CLINICAL STUDIES (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole is chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl] butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/aluminum lake 5627, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "31722-919-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (31722-919-30) ",
"NDC11Code": "31722-0919-30",
"ProductNDC": "31722-919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170808",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see CLINICAL STUDIES (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole is chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl] butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/aluminum lake 5627, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "35356-919-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (35356-919-30) ",
"NDC11Code": "35356-0919-30",
"ProductNDC": "35356-919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"EndMarketingDate": "20280430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076341",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110718",
"EndMarketingDatePackage": "20280430",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with Pravastatin Sodium Tablets, USP should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.",
"Description": "Pravastatin sodium is one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Each tablet, for oral administration contains 10 mg, 20 mg, 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains red ferric oxide, the 20 mg tablet also contains yellow ferric oxide, and the 40 mg tablet also contains a blend of yellow ferric oxide and FD&C blue #1, and the 80 mg tablet also contains yellow ferric oxide."
},
{
"NDCCode": "35356-919-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (35356-919-90) ",
"NDC11Code": "35356-0919-90",
"ProductNDC": "35356-919",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110718",
"EndMarketingDate": "20280430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076341",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110718",
"EndMarketingDatePackage": "20280430",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with Pravastatin Sodium Tablets, USP should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.",
"Description": "Pravastatin sodium is one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Each tablet, for oral administration contains 10 mg, 20 mg, 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains red ferric oxide, the 20 mg tablet also contains yellow ferric oxide, and the 40 mg tablet also contains a blend of yellow ferric oxide and FD&C blue #1, and the 80 mg tablet also contains yellow ferric oxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>57955-0919-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0919-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0919-03</NDC11Code>
<ProductNDC>57955-0919</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rosacea Symptom Relief</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Cardiospermum, Chamomilla, Hydrocotyle Asiatica, Rhus Tox, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; CENTELLA ASIATICA; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 2; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of multiple symptoms of rosacea: facial redness burning stinging allergic skin eruptions itching dermatitis pimples swelling thickening of skin. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0919-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0919-3) </PackageDescription>
<NDC11Code>37662-0919-03</NDC11Code>
<ProductNDC>37662-0919</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lactuca Virosa</ProprietaryName>
<NonProprietaryName>Lactuca Virosa</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220714</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>LACTUCA VIROSA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0919-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0919-3)</PackageDescription>
<NDC11Code>49288-0919-03</NDC11Code>
<ProductNDC>49288-0919</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Treatment Set Ts349631</ProprietaryName>
<NonProprietaryName>Treatment Set Ts349631</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19861031</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN</SubstanceName>
<StrengthNumber>.0004; .002; .0004; .00008; 160; .002; .00008; .00008; .00008; .00008; .0004; .0004; .00008; .00004; .00004; .0004; .001; .001; .0004; .00008; .00008</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.</IndicationAndUsage>
<Description>Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery.</Description>
</NDC>
<NDC>
<NDCCode>50090-0919-3</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (50090-0919-3) </PackageDescription>
<NDC11Code>50090-0919-03</NDC11Code>
<ProductNDC>50090-0919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090485</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 37.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51552-0919-3</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (51552-0919-3)</PackageDescription>
<NDC11Code>51552-0919-03</NDC11Code>
<ProductNDC>51552-0919</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pentravan</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<StartMarketingDate>20120102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>ISOPROPYL MYRISTATE; POLYOXYL 40 STEARATE; STEARYL ALCOHOL; CETYL ALCOHOL; GLYCERYL MONOSTEARATE; STEARIC ACID; UREA</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 1; 1; 1</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57955-0815-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0815-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0815-03</NDC11Code>
<ProductNDC>57955-0815</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mole Remover</ProprietaryName>
<NonProprietaryName>Carbo Vegetabilis, Graphites, Lycopodium Clavatum, Phytolacca Decandra, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140813</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CARBO ANIMALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses † for symptomatic treatment of moles, birthmarks, brown spots, or freckles. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0816-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0816-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0816-03</NDC11Code>
<ProductNDC>57955-0816</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scar Remover</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calcarea Fluorica, Calcarea Phosphorica, Calendula Officinalis, Graphites, Hydrofluoricum Acidum, Phytolacca Decandra, Sabina, Silicea, Thiosinaminum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140318</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; SILICON DIOXIDE; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of scar tissue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0817-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0817-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0817-03</NDC11Code>
<ProductNDC>57955-0817</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cherry Angioma Remover</ProprietaryName>
<NonProprietaryName>Benzoicum Acidum, Calcarea Carbonica, Calcarea Iodata, Iodium, Phosphoricum Acidum, Phosphorus, Sulphuricum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140805</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; IODINE; PHOSPHORIC ACID; PHOSPHORUS; SULFURIC ACID</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of red spots or blood boils associated with angiomas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0818-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-0818-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-0818-03</NDC11Code>
<ProductNDC>57955-0818</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wart Remover</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Causticum, Dulcamara, Kali Muriaticum, Nitricum Acidum, Sabina, Staphysagria, Sulfur, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140318</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; POTASSIUM CHLORIDE; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of smooth or rough warts and dry, itching or unhealthy skin. †as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0920-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0920-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0920-03</NDC11Code>
<ProductNDC>57955-0920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Psoriasis Symptom Relief</ProprietaryName>
<NonProprietaryName>Cardiospermum, Chamomilla, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Lappa Major, Phytolacca Decandra, Rumex Crispus, Ruta Graveolens, Taraxacum Officinale</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>2; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of multiple symptoms of psoriasis: itching rash redness thickening of skin exfoliation of scales and crusts allergic skin eruptions. † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0921-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0921-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0921-03</NDC11Code>
<ProductNDC>57955-0921</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eczema Symptom Relief</ProprietaryName>
<NonProprietaryName>Cardiospermum, Hydrastis Canadensis, Hydrocotyle Asiatica, Lappa Major, Rhus Tox, Rumex Crispus, Ruta Graveolens, Sanguinaria Canadensis, Taraxacum Officinale</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CARDIOSPERMUM HALICACABUM FLOWERING TOP; GOLDENSEAL; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>2; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of eczema: redness intense itching allergic skin eruptions dry or moist eruptions thickened, crusty, scaly skin inflamed skin general unhealthy skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0935-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-0935-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-0935-03</NDC11Code>
<ProductNDC>57955-0935</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warming Arthritic Pain And Joint Relief</ProprietaryName>
<NonProprietaryName>Actaea Spicata, Aescuculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhododendron Chrysanthum, Rhus Tox, Ruta Graveolens, Salicylicum Acidum, Sepia, Zincum Metallicum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of symptoms: minor aches & pains associated with arthitis, backache, leg cramps, stiff, swollen joints, physical weakness, sore tendons and ligaments, body aches, hip & knee discomforts, muscular soreness, restless limbs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-3203-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-3203-3) > 73 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-3203-03</NDC11Code>
<ProductNDC>57955-3203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Gel</ProprietaryName>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160307</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/73g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses Temporarily relieves: swelling form minor injuries muscle pain and stiffness, and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-4000-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-4000-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-4000-03</NDC11Code>
<ProductNDC>57955-4000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothing Advanced Arnica</ProprietaryName>
<NonProprietaryName>Arnica Montana, Arnica Montana, Radix</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120718</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; ARNICA MONTANA ROOT</SubstanceName>
<StrengthNumber>6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: 1 pain or stiffness in muscles or joints, 2 bruising and discoloration, 3 inflammation, 4 soreness after exercise.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-4001-3</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (57955-4001-3) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>57955-4001-03</NDC11Code>
<ProductNDC>57955-4001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cooling Acute Pain Relief</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7301-3</NDCCode>
<PackageDescription>85 g in 1 TUBE (57955-7301-3)</PackageDescription>
<NDC11Code>57955-7301-03</NDC11Code>
<ProductNDC>57955-7301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothing Advanced Arnica</ProprietaryName>
<NonProprietaryName>Arnica Montana, Arnica Montana, Radix</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; ARNICA MONTANA ROOT</SubstanceName>
<StrengthNumber>6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: stiff muscles or joints inflammation bruising and discoloration. soreness after exercise.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7302-3</NDCCode>
<PackageDescription>85 g in 1 TUBE (57955-7302-3)</PackageDescription>
<NDC11Code>57955-7302-03</NDC11Code>
<ProductNDC>57955-7302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cooling Acute Pain Relief</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia, Calcarea Carbonica, Calcarea Fluorica, Cimicifuga Racemosa, Cobaltum Metallicum, Gnaphalium Polycephalum, Hypericum Perforatum, Kali Carbonicum, Kali Phosphoricum, Magnesia Phosphorica, Oxalicum Acidum, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Zincum Metallicum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: back and neck pain muscle and joint pain muscle cramps and stiffness inflamed muscles and joints muscle tension and soreness body aches tired legs and feet stiff and swollen joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-7800-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-7800-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-7800-03</NDC11Code>
<ProductNDC>57955-7800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Tag Remover</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130426</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-8699-3</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (57955-8699-3) > 15 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>57955-8699-03</NDC11Code>
<ProductNDC>57955-8699</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Tag Remover</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic treatment of skin tags. † as per various homeopathic Materia Medicas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10544-919-14</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10544-919-14)</PackageDescription>
<NDC11Code>10544-0919-14</NDC11Code>
<ProductNDC>10544-919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091549</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules, USP and other treatment options before deciding to use Indomethacin Extended-Release Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin Extended-Release Capsules, USP have been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to sever osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendonitis). Indomethacin Extended-Release Capsules, USP are not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more sever forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects. The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not product any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (see PRECAUTIONS, Drug Interactions).</IndicationAndUsage>
<Description>Indomethacin cannot be considered a simple analgesic and should not be used in conditions other than those recommended under INDICATION AND USAGE. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The structural formula is:. M.W. 357.80 C 19H1 6ClNO 4. Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No. 3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>11344-919-65</NDCCode>
<PackageDescription>30 PACKET in 1 POUCH (11344-919-65) > 3 mL in 1 PACKET</PackageDescription>
<NDC11Code>11344-0919-65</NDC11Code>
<ProductNDC>11344-919</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19981113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11673-919-30</NDCCode>
<PackageDescription>3 BOTTLE, DROPPER in 1 CARTON (11673-919-30) / 60 mL in 1 BOTTLE, DROPPER (11673-919-16) </PackageDescription>
<NDC11Code>11673-0919-30</NDC11Code>
<ProductNDC>11673-919</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Hair Regrowth Treatment For Women</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075357</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0919-0</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (11822-0919-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-0919-00</NDC11Code>
<ProductNDC>11822-0919</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076011</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-919-01</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-919-01) </PackageDescription>
<NDC11Code>16714-0919-01</NDC11Code>
<ProductNDC>16714-919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206156</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.</IndicationAndUsage>
<Description>Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride extended-release tablets, 0.375 mg. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride, USP. Pramipexole dihydrochloride extended-release tablets, 0.75 mg. Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 1.5 mg. Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 2.25 mg. Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 3 mg. Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride,USP. Pramipexole dihydrochloride extended-release tablets, 4.5 mg. Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride,USP. Inactive ingredients for all strengths of pramipexole dihydrochloride extended-release tablets consist of hypromellose, mannitol, pregelatinized starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>21695-919-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (21695-919-90)</PackageDescription>
<NDC11Code>21695-0919-90</NDC11Code>
<ProductNDC>21695-919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diovan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021283</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diovan is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension (1.1), 2 Treatment of heart failure (NYHA class II-IV); Diovan significantly reduced hospitalization for heart failure (1.2), 3 Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction (1.3).</IndicationAndUsage>
<Description>Diovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Diovan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>30142-919-56</NDCCode>
<PackageDescription>226 g in 1 BOTTLE, PLASTIC (30142-919-56)</PackageDescription>
<NDC11Code>30142-0919-56</NDC11Code>
<ProductNDC>30142-919</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Sport Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THE KROGER CO</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 13; 5; 5; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in the water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-919-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-919-01) </PackageDescription>
<NDC11Code>31722-0919-01</NDC11Code>
<ProductNDC>31722-919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see CLINICAL STUDIES (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole is chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl] butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/aluminum lake 5627, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>31722-919-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (31722-919-30) </PackageDescription>
<NDC11Code>31722-0919-30</NDC11Code>
<ProductNDC>31722-919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see CLINICAL STUDIES (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole is chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl] butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/aluminum lake 5627, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>35356-919-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (35356-919-30) </PackageDescription>
<NDC11Code>35356-0919-30</NDC11Code>
<ProductNDC>35356-919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<EndMarketingDate>20280430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076341</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110718</StartMarketingDatePackage>
<EndMarketingDatePackage>20280430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with Pravastatin Sodium Tablets, USP should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.</IndicationAndUsage>
<Description>Pravastatin sodium is one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Each tablet, for oral administration contains 10 mg, 20 mg, 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains red ferric oxide, the 20 mg tablet also contains yellow ferric oxide, and the 40 mg tablet also contains a blend of yellow ferric oxide and FD&C blue #1, and the 80 mg tablet also contains yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>35356-919-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (35356-919-90) </PackageDescription>
<NDC11Code>35356-0919-90</NDC11Code>
<ProductNDC>35356-919</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110718</StartMarketingDate>
<EndMarketingDate>20280430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076341</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110718</StartMarketingDatePackage>
<EndMarketingDatePackage>20280430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with Pravastatin Sodium Tablets, USP should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors.</IndicationAndUsage>
<Description>Pravastatin sodium is one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural formula. Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Each tablet, for oral administration contains 10 mg, 20 mg, 40 mg or 80 mg of pravastatin sodium. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains red ferric oxide, the 20 mg tablet also contains yellow ferric oxide, and the 40 mg tablet also contains a blend of yellow ferric oxide and FD&C blue #1, and the 80 mg tablet also contains yellow ferric oxide.</Description>
</NDC>
</NDCList>