{
"NDC": [
{
"NDCCode": "59088-432-07",
"PackageDescription": "85 g in 1 TUBE (59088-432-07) ",
"NDC11Code": "59088-0432-07",
"ProductNDC": "59088-432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Radiaura Skin Recovery",
"NonProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210902",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "30; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210902",
"SamplePackage": "N",
"IndicationAndUsage": "The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.",
"Description": "Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula. Radiaura Skin Recovery Cream Lidocaine HCl 3%- Hydrocortisone Acetate 0.5% Each gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg. ACTIVE INGREDIENTS. Lidocaine HCl 3% (30 mg). Hydrocortisone Acetate 0.5% (5 mg)."
},
{
"NDCCode": "24236-432-07",
"PackageDescription": "12 TABLET in 1 BLISTER PACK (24236-432-07)",
"NDC11Code": "24236-0432-07",
"ProductNDC": "24236-432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089883",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2016-03-11"
},
{
"NDCCode": "52959-432-07",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (52959-432-07)",
"NDC11Code": "52959-0432-07",
"ProductNDC": "52959-432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087022",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride, USP has the chemical name of α,α-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as: 1 a) powder-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D&C Red # 28, and FD&C Blue # 1; the yellow/yellow capsules contain gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the black/black capsules contain gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone., 2 b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: sugar spheres, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80, FD&C Blue # 2 Aluminum Lake, FD&C Blue # 1, and gelatin. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "67046-432-07",
"PackageDescription": "7 CAPSULE in 1 BLISTER PACK (67046-432-07) ",
"NDC11Code": "67046-0432-07",
"ProductNDC": "67046-432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lithium Carbonate",
"NonProprietaryName": "Lithium Carbonate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090702",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "LITHIUM CARBONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170919",
"SamplePackage": "N",
"IndicationAndUsage": "Lithium Carbonate Capsule USP is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium Carbonate Capsule USP is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.",
"Description": "Each capsule for oral administration contains 150 mg, 300 mg or 600 mg of Lithium Carbonate USP. Inactive Ingredients. The capsules contain talc. The hard gelatin shell consists of gelatin, titanium dioxide, sodium lauryl sulphate and FD & C Red 40. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide E172 dye, potassium hydroxide. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The empirical formula for Lithium Citrate is C 6H 5Li 3O 7; molecular weight 209.92. Lithium acts as an antimanic. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li 2CO 3 and molecular weight 73.89."
},
{
"NDCCode": "69168-432-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (69168-432-07) / 10 TABLET in 1 BOTTLE",
"NDC11Code": "69168-0432-07",
"ProductNDC": "69168-432",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Dm",
"ProprietaryNameSuffix": "Immediate Release",
"NonProprietaryName": "Mucus Relief Dm",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220518",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Allegiant Health",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220518",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "71919-432-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-432-07) ",
"NDC11Code": "71919-0432-07",
"ProductNDC": "71919-432",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesium Metallicum",
"NonProprietaryName": "Magnesium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111013",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MAGNESIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20111013",
"SamplePackage": "N"
},
{
"NDCCode": "59088-083-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-083-00) * 9 BLISTER PACK in 1 CARTON (55111-292-09) / 9 TABLET in 1 BLISTER PACK * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) ",
"NDC11Code": "59088-0083-00",
"ProductNDC": "59088-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranow",
"NonProprietaryName": "Sumatriptan Succinate, Camphor, Menthol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160418",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160418",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.",
"Description": "Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin."
},
{
"NDCCode": "59088-202-07",
"PackageDescription": "85 g in 1 TUBE (59088-202-07) ",
"NDC11Code": "59088-0202-07",
"ProductNDC": "59088-202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menticam",
"NonProprietaryName": "Camphor,menthol, Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231026",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE",
"StrengthNumber": "4; 7.5; 10",
"StrengthUnit": "g/85g; g/85g; g/85g",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231026",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "59088-203-07",
"PackageDescription": "100 g in 1 TUBE (59088-203-07) ",
"NDC11Code": "59088-0203-07",
"ProductNDC": "59088-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menticam",
"NonProprietaryName": "Camphor, Menthol, Methyl Salicylate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231026",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "10; 30; 4",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231026",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "59088-204-07",
"PackageDescription": "85 g in 1 TUBE (59088-204-07) ",
"NDC11Code": "59088-0204-07",
"ProductNDC": "59088-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidotral 5% Gel",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240725",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Puretek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240725",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain.",
"Description": "Lidotral® 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure."
},
{
"NDCCode": "59088-206-07",
"PackageDescription": "85 g in 1 TUBE (59088-206-07) ",
"NDC11Code": "59088-0206-07",
"ProductNDC": "59088-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fungizyl Ac",
"NonProprietaryName": "Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241204",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Puretek Corporation",
"SubstanceName": "DIMETHYL SULFOXIDE; MICONAZOLE NITRATE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241204",
"SamplePackage": "N",
"IndicationAndUsage": "Fungizyl AC is indicated for the treatment of fungal infections of the skin, including athlete's foot, jock itch, and ringworm. It also helps with superficial skin infections caused by Candida species. Dimethyl Sulfoxide (DMSO) enhances the penetration of Miconazole Nitrate through the skin, improving antifungal effectiveness.",
"Description": "Fungizyl AC is a topical antifungal formulation that combines Dimethyl Sulfoxide (DMSO) and Miconazole Nitrate with a mixture of emollients and essential oils. The formulation is designed to provide effective antifungal activity while also soothing and moisturizing the skin. Each gram of Fungizyl AC contains 20 mg of Dimethyl Sulfoxide and 20 mg of Miconazole Nitrate in a vehicle with Aleurites Moluccana (Kukui) Seed Oil, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cety Alcohol, Cetyl Phosphate, Chlorphenesin, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, DL-Alpha-Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Sodium Hydroxide, and Stearyl Alcohol."
},
{
"NDCCode": "59088-207-07",
"PackageDescription": "85 g in 1 TUBE (59088-207-07) ",
"NDC11Code": "59088-0207-07",
"ProductNDC": "59088-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lasolex Ag",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251203",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Puretek Corporation",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251203",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort."
},
{
"NDCCode": "59088-212-07",
"PackageDescription": "85 g in 1 TUBE (59088-212-07) ",
"NDC11Code": "59088-0212-07",
"ProductNDC": "59088-212",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Exemax Cream",
"NonProprietaryName": "Dimethicone, Allantoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250702",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALLANTOIN; DIMETHICONE",
"StrengthNumber": "2; 5",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250702",
"SamplePackage": "N",
"IndicationAndUsage": "● temporarily protects and helps relieve chapped or cracked skin ● helps protect from the drying effects of wind and cold weather.",
"Description": "Drug Facts."
},
{
"NDCCode": "59088-221-07",
"PackageDescription": "85 g in 1 TUBE (59088-221-07) ",
"NDC11Code": "59088-0221-07",
"ProductNDC": "59088-221",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidoease 2%",
"NonProprietaryName": "Lidocaine Hcl 2%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250806",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250806",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporarily relief of pain and itching associated with: ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations."
},
{
"NDCCode": "59088-239-07",
"PackageDescription": "85 g in 1 TUBE (59088-239-07) ",
"NDC11Code": "59088-0239-07",
"ProductNDC": "59088-239",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lasolex Ac",
"NonProprietaryName": "Miconazole Nitrate 2% Antifungal",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, itchy, scaly skin between the toes, or itching, burning feet."
},
{
"NDCCode": "59088-241-07",
"PackageDescription": "85 g in 1 TUBE (59088-241-07) ",
"NDC11Code": "59088-0241-07",
"ProductNDC": "59088-241",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine 3%",
"NonProprietaryName": "Lidocaine Hcl 3%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250812",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250812",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporarily relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, or poison sumac."
},
{
"NDCCode": "59088-244-07",
"PackageDescription": "85 g in 1 BOTTLE (59088-244-07) ",
"NDC11Code": "59088-0244-07",
"ProductNDC": "59088-244",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Feminine Intimate Powder",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190531",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190531",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment and relief of external genital itching. relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with external genital itching."
},
{
"NDCCode": "59088-247-07",
"PackageDescription": "85 g in 1 TUBE (59088-247-07) ",
"NDC11Code": "59088-0247-07",
"ProductNDC": "59088-247",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine 5% Gel",
"NonProprietaryName": "Lidocaine Hcl 5%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250919",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Puretek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250919",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain.",
"Description": "Lidocaine 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure."
},
{
"NDCCode": "59088-259-07",
"PackageDescription": "85 g in 1 BOTTLE, WITH APPLICATOR (59088-259-07) ",
"NDC11Code": "59088-0259-07",
"ProductNDC": "59088-259",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camphor 4% Plus Menthol 10%",
"NonProprietaryName": "Camphor 4% Plus Menthol 10%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250820",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MENTHOL; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "100; 40",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250820",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc."
},
{
"NDCCode": "59088-283-07",
"PackageDescription": "85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) ",
"NDC11Code": "59088-0283-07",
"ProductNDC": "59088-283",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camphotrex",
"NonProprietaryName": "Camphor, Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160412",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL",
"StrengthNumber": "4; 10",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160412",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc."
},
{
"NDCCode": "59088-307-07",
"PackageDescription": "85 g in 1 BOTTLE (59088-307-07) ",
"NDC11Code": "59088-0307-07",
"ProductNDC": "59088-307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidotral 3.88% Roll On",
"NonProprietaryName": "Lidocaine Hci",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240228",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "38.8",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
"Description": "Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:."
},
{
"NDCCode": "59088-317-07",
"PackageDescription": "85 g in 1 TUBE (59088-317-07) ",
"NDC11Code": "59088-0317-07",
"ProductNDC": "59088-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream",
"NonProprietaryName": "Lidocaine Hcl, Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "38.8; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburns or minor skin irritations or hemorrhoids and itching associated with inflammation, and rashes due to eczema.",
"Description": "Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula."
},
{
"NDCCode": "59088-319-07",
"PackageDescription": "85 g in 1 TUBE (59088-319-07) ",
"NDC11Code": "59088-0319-07",
"ProductNDC": "59088-319",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidotral 5 Percent And Hydrocortisone 1 Percent With Peptides And Arnica",
"NonProprietaryName": "Lidocaine Hcl 5 % , Hydrocortisone Acetate 1%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240315",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "50; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240315",
"SamplePackage": "N",
"IndicationAndUsage": "The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.",
"Description": "Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula. Lidotral 5% + Hydrocortisone 1% Cream with Peptides & Arnica Each gram contains Lidocaine HCl 50 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: Lidocaine HCl 5% Hydrocortisone Acetate 1%."
},
{
"NDCCode": "59088-321-07",
"PackageDescription": "85 g in 1 TUBE (59088-321-07) ",
"NDC11Code": "59088-0321-07",
"ProductNDC": "59088-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurozyl",
"NonProprietaryName": "Lidocaine Hcl 4.12 %",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "41.2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240613",
"SamplePackage": "N",
"IndicationAndUsage": "Neurozyl Cream is indicated for the temporary relief of pain.",
"Description": "Neurozyl Cream contains 41.2 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Bis (tripeptide-1) Copper Acetate, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Curcuma Longa (Turmeric) Root Extract, Ethylhexylglycerin, Glycerin, Mineral Oil, Oat Straw (Avena Sativa) Powder, Passiflora Incarnata Fruit Extract, Petrolatum, Phenoxyethanol, Propylene Glycol, Salix Alba (Willow) Bark Extract, Scutellaria Baicalensis (Chinese Skullcap) Root Extract, Sodium Phosphate. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:."
},
{
"NDCCode": "59088-326-07",
"PackageDescription": "85 g in 1 TUBE (59088-326-07) ",
"NDC11Code": "59088-0326-07",
"ProductNDC": "59088-326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scartrate Cream",
"NonProprietaryName": "Dimethicone, Allantoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240718",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Puretek Corporation",
"SubstanceName": "ALLANTOIN; DIMETHICONE",
"StrengthNumber": "22.5; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240718",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Scartrate Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.",
"Description": "Scartrate Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance."
},
{
"NDCCode": "59088-327-07",
"PackageDescription": "85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) ",
"NDC11Code": "59088-0327-07",
"ProductNDC": "59088-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidotral 5 Percent Roll On Gel",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240802",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Puretek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240802",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain.",
"Description": "Lidotral® 5% Roll on Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Cyclopentasiloxane, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure."
},
{
"NDCCode": "59088-329-07",
"PackageDescription": "85 g in 1 BOTTLE (59088-329-07) ",
"NDC11Code": "59088-0329-07",
"ProductNDC": "59088-329",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Penetral Roll-on",
"NonProprietaryName": "Capsaicin 0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260714",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CAPSICUM OLEORESIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260714",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises, and sprains. ■ Provides warming pain relief."
},
{
"NDCCode": "59088-371-07",
"PackageDescription": "1 TUBE in 1 CARTON (59088-371-07) > 85 g in 1 TUBE",
"NDC11Code": "59088-0371-07",
"ProductNDC": "59088-371",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Lidotral",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151203",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "38.8",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2019-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151203",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
"Description": "Lidotral (Lidocaine HCl) 3.88% Cream contains Lidocaine HCl 3.88% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Ingredients: Each gram of Lidotral 3.88% Cream contains Lidocaine HCl USP 38.8 mg. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic."
},
{
"NDCCode": "59088-429-07",
"PackageDescription": "1 TUBE in 1 CARTON (59088-429-07) > 85 g in 1 TUBE",
"NDC11Code": "59088-0429-07",
"ProductNDC": "59088-429",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lydexa 4.12%",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200710",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "41.2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2022-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220302",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
"Description": "Contains lidocaine HCl 4.12% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Ingredients: Each gram of Lydexa 4.12% Cream contains Lidocaine HCl USP 4.12%. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic."
},
{
"NDCCode": "59088-441-07",
"PackageDescription": "85 g in 1 TUBE (59088-441-07) ",
"NDC11Code": "59088-0441-07",
"ProductNDC": "59088-441",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mycozyl Ac",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210406",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210406",
"SamplePackage": "N",
"IndicationAndUsage": "■ For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). ■ Relieves itching, burning, cracking, scaling, and discomfort which accompanies these conditions."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59088-432-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-432-07) </PackageDescription>
<NDC11Code>59088-0432-07</NDC11Code>
<ProductNDC>59088-432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Radiaura Skin Recovery</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210902</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>30; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.</IndicationAndUsage>
<Description>Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula. Radiaura Skin Recovery Cream Lidocaine HCl 3%- Hydrocortisone Acetate 0.5% Each gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg. ACTIVE INGREDIENTS. Lidocaine HCl 3% (30 mg). Hydrocortisone Acetate 0.5% (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>24236-432-07</NDCCode>
<PackageDescription>12 TABLET in 1 BLISTER PACK (24236-432-07)</PackageDescription>
<NDC11Code>24236-0432-07</NDC11Code>
<ProductNDC>24236-432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089883</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-03-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>52959-432-07</NDCCode>
<PackageDescription>7 CAPSULE in 1 BOTTLE (52959-432-07)</PackageDescription>
<NDC11Code>52959-0432-07</NDC11Code>
<ProductNDC>52959-432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087022</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride, USP has the chemical name of α,α-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as: 1 a) powder-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D&C Red # 28, and FD&C Blue # 1; the yellow/yellow capsules contain gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the black/black capsules contain gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone., 2 b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: sugar spheres, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80, FD&C Blue # 2 Aluminum Lake, FD&C Blue # 1, and gelatin. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>67046-432-07</NDCCode>
<PackageDescription>7 CAPSULE in 1 BLISTER PACK (67046-432-07) </PackageDescription>
<NDC11Code>67046-0432-07</NDC11Code>
<ProductNDC>67046-432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lithium Carbonate</ProprietaryName>
<NonProprietaryName>Lithium Carbonate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090702</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>LITHIUM CARBONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lithium Carbonate Capsule USP is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium Carbonate Capsule USP is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.</IndicationAndUsage>
<Description>Each capsule for oral administration contains 150 mg, 300 mg or 600 mg of Lithium Carbonate USP. Inactive Ingredients. The capsules contain talc. The hard gelatin shell consists of gelatin, titanium dioxide, sodium lauryl sulphate and FD & C Red 40. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide E172 dye, potassium hydroxide. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The empirical formula for Lithium Citrate is C 6H 5Li 3O 7; molecular weight 209.92. Lithium acts as an antimanic. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li 2CO 3 and molecular weight 73.89.</Description>
</NDC>
<NDC>
<NDCCode>69168-432-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69168-432-07) / 10 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>69168-0432-07</NDC11Code>
<ProductNDC>69168-432</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Dm</ProprietaryName>
<ProprietaryNameSuffix>Immediate Release</ProprietaryNameSuffix>
<NonProprietaryName>Mucus Relief Dm</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220518</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Allegiant Health</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-432-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-432-07) </PackageDescription>
<NDC11Code>71919-0432-07</NDC11Code>
<ProductNDC>71919-432</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesium Metallicum</ProprietaryName>
<NonProprietaryName>Magnesium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111013</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MAGNESIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-083-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-083-00) * 9 BLISTER PACK in 1 CARTON (55111-292-09) / 9 TABLET in 1 BLISTER PACK * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) </PackageDescription>
<NDC11Code>59088-0083-00</NDC11Code>
<ProductNDC>59088-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranow</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate, Camphor, Menthol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160418</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
<Description>Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>59088-202-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-202-07) </PackageDescription>
<NDC11Code>59088-0202-07</NDC11Code>
<ProductNDC>59088-202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menticam</ProprietaryName>
<NonProprietaryName>Camphor,menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231026</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>4; 7.5; 10</StrengthNumber>
<StrengthUnit>g/85g; g/85g; g/85g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-203-07</NDCCode>
<PackageDescription>100 g in 1 TUBE (59088-203-07) </PackageDescription>
<NDC11Code>59088-0203-07</NDC11Code>
<ProductNDC>59088-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menticam</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231026</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>10; 30; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-204-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-204-07) </PackageDescription>
<NDC11Code>59088-0204-07</NDC11Code>
<ProductNDC>59088-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidotral 5% Gel</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240725</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
<Description>Lidotral® 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>59088-206-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-206-07) </PackageDescription>
<NDC11Code>59088-0206-07</NDC11Code>
<ProductNDC>59088-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fungizyl Ac</ProprietaryName>
<NonProprietaryName>Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>DIMETHYL SULFOXIDE; MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fungizyl AC is indicated for the treatment of fungal infections of the skin, including athlete's foot, jock itch, and ringworm. It also helps with superficial skin infections caused by Candida species. Dimethyl Sulfoxide (DMSO) enhances the penetration of Miconazole Nitrate through the skin, improving antifungal effectiveness.</IndicationAndUsage>
<Description>Fungizyl AC is a topical antifungal formulation that combines Dimethyl Sulfoxide (DMSO) and Miconazole Nitrate with a mixture of emollients and essential oils. The formulation is designed to provide effective antifungal activity while also soothing and moisturizing the skin. Each gram of Fungizyl AC contains 20 mg of Dimethyl Sulfoxide and 20 mg of Miconazole Nitrate in a vehicle with Aleurites Moluccana (Kukui) Seed Oil, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cety Alcohol, Cetyl Phosphate, Chlorphenesin, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, DL-Alpha-Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Sodium Hydroxide, and Stearyl Alcohol.</Description>
</NDC>
<NDC>
<NDCCode>59088-207-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-207-07) </PackageDescription>
<NDC11Code>59088-0207-07</NDC11Code>
<ProductNDC>59088-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lasolex Ag</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-212-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-212-07) </PackageDescription>
<NDC11Code>59088-0212-07</NDC11Code>
<ProductNDC>59088-212</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Exemax Cream</ProprietaryName>
<NonProprietaryName>Dimethicone, Allantoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250702</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALLANTOIN; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● temporarily protects and helps relieve chapped or cracked skin ● helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
<Description>Drug Facts.</Description>
</NDC>
<NDC>
<NDCCode>59088-221-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-221-07) </PackageDescription>
<NDC11Code>59088-0221-07</NDC11Code>
<ProductNDC>59088-221</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidoease 2%</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl 2%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250806</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporarily relief of pain and itching associated with: ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-239-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-239-07) </PackageDescription>
<NDC11Code>59088-0239-07</NDC11Code>
<ProductNDC>59088-239</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lasolex Ac</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate 2% Antifungal</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, itchy, scaly skin between the toes, or itching, burning feet.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-241-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-241-07) </PackageDescription>
<NDC11Code>59088-0241-07</NDC11Code>
<ProductNDC>59088-241</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine 3%</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl 3%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250812</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporarily relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, or poison sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-244-07</NDCCode>
<PackageDescription>85 g in 1 BOTTLE (59088-244-07) </PackageDescription>
<NDC11Code>59088-0244-07</NDC11Code>
<ProductNDC>59088-244</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Feminine Intimate Powder</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment and relief of external genital itching. relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with external genital itching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-247-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-247-07) </PackageDescription>
<NDC11Code>59088-0247-07</NDC11Code>
<ProductNDC>59088-247</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine 5% Gel</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl 5%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250919</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
<Description>Lidocaine 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>59088-259-07</NDCCode>
<PackageDescription>85 g in 1 BOTTLE, WITH APPLICATOR (59088-259-07) </PackageDescription>
<NDC11Code>59088-0259-07</NDC11Code>
<ProductNDC>59088-259</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camphor 4% Plus Menthol 10%</ProprietaryName>
<NonProprietaryName>Camphor 4% Plus Menthol 10%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250820</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>100; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-283-07</NDCCode>
<PackageDescription>85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) </PackageDescription>
<NDC11Code>59088-0283-07</NDC11Code>
<ProductNDC>59088-283</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camphotrex</ProprietaryName>
<NonProprietaryName>Camphor, Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160412</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL</SubstanceName>
<StrengthNumber>4; 10</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-307-07</NDCCode>
<PackageDescription>85 g in 1 BOTTLE (59088-307-07) </PackageDescription>
<NDC11Code>59088-0307-07</NDC11Code>
<ProductNDC>59088-307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidotral 3.88% Roll On</ProprietaryName>
<NonProprietaryName>Lidocaine Hci</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38.8</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
<Description>Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>59088-317-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-317-07) </PackageDescription>
<NDC11Code>59088-0317-07</NDC11Code>
<ProductNDC>59088-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl, Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>38.8; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburns or minor skin irritations or hemorrhoids and itching associated with inflammation, and rashes due to eczema.</IndicationAndUsage>
<Description>Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>59088-319-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-319-07) </PackageDescription>
<NDC11Code>59088-0319-07</NDC11Code>
<ProductNDC>59088-319</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidotral 5 Percent And Hydrocortisone 1 Percent With Peptides And Arnica</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl 5 % , Hydrocortisone Acetate 1%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>50; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.</IndicationAndUsage>
<Description>Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula. Lidotral 5% + Hydrocortisone 1% Cream with Peptides & Arnica Each gram contains Lidocaine HCl 50 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: Lidocaine HCl 5% Hydrocortisone Acetate 1%.</Description>
</NDC>
<NDC>
<NDCCode>59088-321-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-321-07) </PackageDescription>
<NDC11Code>59088-0321-07</NDC11Code>
<ProductNDC>59088-321</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurozyl</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl 4.12 %</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>41.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Neurozyl Cream is indicated for the temporary relief of pain.</IndicationAndUsage>
<Description>Neurozyl Cream contains 41.2 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Bis (tripeptide-1) Copper Acetate, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Curcuma Longa (Turmeric) Root Extract, Ethylhexylglycerin, Glycerin, Mineral Oil, Oat Straw (Avena Sativa) Powder, Passiflora Incarnata Fruit Extract, Petrolatum, Phenoxyethanol, Propylene Glycol, Salix Alba (Willow) Bark Extract, Scutellaria Baicalensis (Chinese Skullcap) Root Extract, Sodium Phosphate. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>59088-326-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-326-07) </PackageDescription>
<NDC11Code>59088-0326-07</NDC11Code>
<ProductNDC>59088-326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scartrate Cream</ProprietaryName>
<NonProprietaryName>Dimethicone, Allantoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240718</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>ALLANTOIN; DIMETHICONE</SubstanceName>
<StrengthNumber>22.5; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240718</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scartrate Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.</IndicationAndUsage>
<Description>Scartrate Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.</Description>
</NDC>
<NDC>
<NDCCode>59088-327-07</NDCCode>
<PackageDescription>85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) </PackageDescription>
<NDC11Code>59088-0327-07</NDC11Code>
<ProductNDC>59088-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidotral 5 Percent Roll On Gel</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240802</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
<Description>Lidotral® 5% Roll on Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Cyclopentasiloxane, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>59088-329-07</NDCCode>
<PackageDescription>85 g in 1 BOTTLE (59088-329-07) </PackageDescription>
<NDC11Code>59088-0329-07</NDC11Code>
<ProductNDC>59088-329</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Penetral Roll-on</ProprietaryName>
<NonProprietaryName>Capsaicin 0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CAPSICUM OLEORESIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises, and sprains. ■ Provides warming pain relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-371-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59088-371-07) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0371-07</NDC11Code>
<ProductNDC>59088-371</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Lidotral</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38.8</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
<Description>Lidotral (Lidocaine HCl) 3.88% Cream contains Lidocaine HCl 3.88% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Ingredients: Each gram of Lidotral 3.88% Cream contains Lidocaine HCl USP 38.8 mg. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic.</Description>
</NDC>
<NDC>
<NDCCode>59088-429-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59088-429-07) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0429-07</NDC11Code>
<ProductNDC>59088-429</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lydexa 4.12%</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>41.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
<Description>Contains lidocaine HCl 4.12% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Ingredients: Each gram of Lydexa 4.12% Cream contains Lidocaine HCl USP 4.12%. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic.</Description>
</NDC>
<NDC>
<NDCCode>59088-441-07</NDCCode>
<PackageDescription>85 g in 1 TUBE (59088-441-07) </PackageDescription>
<NDC11Code>59088-0441-07</NDC11Code>
<ProductNDC>59088-441</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mycozyl Ac</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210406</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). ■ Relieves itching, burning, cracking, scaling, and discomfort which accompanies these conditions.</IndicationAndUsage>
</NDC>
</NDCList>