{
"NDC": [
{
"NDCCode": "83021-617-05",
"PackageDescription": "5 mL in 1 VIAL, GLASS (83021-617-05) ",
"NDC11Code": "83021-0617-05",
"ProductNDC": "83021-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Allantoin",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221021",
"EndMarketingDate": "20270920",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "PROPYLPARABEN; ALLANTOIN; PANTHENOL; FD&C YELLOW NO. 5; PROPYLENE GLYCOL; ARCTIUM LAPPA ROOT; METHYLPARABEN; TIOXOLONE; WATER; ALCOHOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; YEAST, UNSPECIFIED; ASCORBYL PALMITATE; RIBOFLAVIN; ETHYLPARABEN; TOCOPHEROL; CITRAL; LIMONENE, (+)-; POWDERED CELLULOSE; ISOPROPYL ALCOHOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; LEVOMENOL; FARNESOL; FRAGRANCE 13576; PHENOXYETHANOL; BUTYLPARABEN; NIACINAMIDE",
"StrengthNumber": ".0000001; .0125; .0025; .00001; .0069; .000035; .00500065; .01; 3.12515585; 1.756; .02; .01725; .00005; .000003; .00000015; .000001; .000097; .002095; .0003; .0006; .017; .0045; .0005; .01; .000003; .00000025; .0001",
"StrengthUnit": "g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; mL/5mL; mL/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221021",
"EndMarketingDatePackage": "20270920",
"SamplePackage": "N"
},
{
"NDCCode": "31722-617-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (31722-617-05) ",
"NDC11Code": "31722-0617-05",
"ProductNDC": "31722-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206912",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191008",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "42192-617-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (42192-617-05) ",
"NDC11Code": "42192-0617-05",
"ProductNDC": "42192-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210802",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091310",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210802",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate; with a molecular weight of 603.0. Each benzonatate capsule USP, 100 mg contains: Benzonatate, USP 100 mg. Each benzonatate capsule USP, 200 mg contains: Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: gelatin 175 bloom bone NF, glycerin 99% USP, methyl/propyl paraben blend (4:1 ), yellow #10-DC and white ink (shellac glaze in SD-45, titanium dioxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and simethicone)."
},
{
"NDCCode": "50742-617-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-617-05) ",
"NDC11Code": "50742-0617-05",
"ProductNDC": "50742-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204106",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180206",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5."
},
{
"NDCCode": "53666-617-01",
"PackageDescription": "30 BLISTER PACK in 1 BOX (53666-617-01) > .05 g in 1 BLISTER PACK",
"NDC11Code": "53666-0617-01",
"ProductNDC": "53666-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Desenfriol-d",
"NonProprietaryName": "Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171018",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Salimex, S.A.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": ".002; .005; .5",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171018",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies:. headache. sinus congestion and pressure. nasal congestion. runny nose and sneezing. minor aches and pains. temporarily relieves these additional symptoms of hay fever:. itching of the nose or throat. itchy, watery eyes. helps clear nasal passages. helps decongest sinus openings and passages."
},
{
"NDCCode": "53746-617-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (53746-617-05) ",
"NDC11Code": "53746-0617-05",
"ProductNDC": "53746-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091217",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-617-05",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (55111-617-05) ",
"NDC11Code": "55111-0617-05",
"ProductNDC": "55111-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091024",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140415",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets are administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its molecular formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone USP is a white to slightly yellowish powder. Eszopiclone is soluble in methylene chloride, practically insoluble in water and alcohol. It dissolves in dilute mineral acids. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcelac 100 (lactose monohydrate and cellulose, microcrystalline), polyethylene glycol and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2 and triacetin."
},
{
"NDCCode": "58602-617-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-617-05) / 89 mL in 1 BOTTLE",
"NDC11Code": "58602-0617-05",
"ProductNDC": "58602-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dextromethorphan Polistirex",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218417",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "DEXTROMETHORPHAN",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "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": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep."
},
{
"NDCCode": "65841-617-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65841-617-05) ",
"NDC11Code": "65841-0617-05",
"ProductNDC": "65841-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077614",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N"
},
{
"NDCCode": "68428-617-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-617-05) ",
"NDC11Code": "68428-0617-05",
"ProductNDC": "68428-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salvia Officinalis",
"NonProprietaryName": "Sage",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091016",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SAGE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20091016",
"SamplePackage": "N"
},
{
"NDCCode": "75839-617-05",
"PackageDescription": ".5 kg in 1 CONTAINER (75839-617-05)",
"NDC11Code": "75839-0617-05",
"ProductNDC": "75839-617",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dexamethasone Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161014",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "DEXAMETHASONE ACETATE, UNSPECIFIED FORM",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "83021-033-01",
"PackageDescription": "250 mL in 1 BOTTLE, SPRAY (83021-033-01) ",
"NDC11Code": "83021-0033-01",
"ProductNDC": "83021-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona New Even",
"NonProprietaryName": "Lactic Acid, Citric Acid, Glycolic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221013",
"EndMarketingDate": "20270113",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "FD&C BLUE NO. 1; LACTIC ACID; POLYOXYL 40 HYDROGENATED CASTOR OIL; TROLAMINE; .ALPHA.-HEXYLCINNAMALDEHYDE; LINALOOL, (+/-)-; BENZOIC ACID; PHENOXYETHANOL; GLYCOLIC ACID; WATER; ALLANTOIN; DEHYDROACETIC ACID; DIETHYLENE GLYCOL MONOETHYL ETHER; FRAGRANCE 13576; LIMONENE, (+)-; PROPYLENE GLYCOL",
"StrengthNumber": ".0005; 2.348125; 1.25; .5; .0150375; .0041025; .625; 2.5; 1.220625; 228.15635; .75; .25; .75; .075; .022755; 10.5",
"StrengthUnit": "g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; mL/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL",
"Pharm_Classes": "Acidifying Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221013",
"EndMarketingDatePackage": "20270113",
"SamplePackage": "N"
},
{
"NDCCode": "83021-187-01",
"PackageDescription": "200 mL in 1 TUBE (83021-187-01) ",
"NDC11Code": "83021-0187-01",
"ProductNDC": "83021-187",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Vital Line",
"NonProprietaryName": "Hydrolyzed Elastin, Hydrolysed Collagen, Cocoglycerides",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221025",
"EndMarketingDate": "20261020",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "AVOBENZONE; PHENOXYETHANOL; FRAGRANCE 13576; DEHYDROACETIC ACID; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); OCTINOXATE; COCO-GLYCERIDES; GLYCERIN; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); CETOSTEARYL ALCOHOL; MEDIUM-CHAIN TRIGLYCERIDES; CETYL ALCOHOL; .ALPHA.-HEXYLCINNAMALDEHYDE; WATER; BENZOIC ACID; CENTAUREA CYANUS FLOWER; VIOLA ODORATA; LIMONENE, (+)-; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; .BETA.-CITRONELLOL, (R)-; ISOMETHYL-.ALPHA.-IONONE; BUTYLATED HYDROXYTOLUENE",
"StrengthNumber": "2; 1.62; .98; .14; .03; 5; 8; 6.94; .6; 12.58; 12; 4; .16; 140; .24; .05; .05; .038; .006; .0056; .0054; .005",
"StrengthUnit": "g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL",
"Pharm_Classes": "Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221025",
"EndMarketingDatePackage": "20261020",
"SamplePackage": "N"
},
{
"NDCCode": "83021-300-01",
"PackageDescription": "200 mL in 1 TUBE (83021-300-01) ",
"NDC11Code": "83021-0300-01",
"ProductNDC": "83021-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Regul Oil",
"NonProprietaryName": "Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (hops) Cone Extract",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221020",
"EndMarketingDate": "20280203",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "ARCTIUM LAPPA ROOT; POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE); LAURETH-7; PEG/PPG-20/6 DIMETHICONE; ALCOHOL; GLYCERIN; CETEARYL ETHYLHEXANOATE; LIMONENE, (+)-; PANTHENOL; IMIDUREA; FD&C YELLOW NO. 5; RIBOFLAVIN; PHENOXYETHANOL; FRAGRANCE 13576; WATER; CETOSTEARYL ALCOHOL; PROPYLENE GLYCOL; MINERAL OIL; ETHYLHEXYLGLYCERIN; METHYLCHLOROISOTHIAZOLINONE; METHYLISOTHIAZOLINONE; HOPS; TIOXOLONE; PROPYLPARABEN; YEAST, UNSPECIFIED; NIACINAMIDE; C13-14 ISOPARAFFIN; METHYLPARABEN; GLYCERYL STEARATE SE; TRIISOPROPANOLAMINE; PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221020",
"EndMarketingDatePackage": "20280203",
"SamplePackage": "N"
},
{
"NDCCode": "83021-305-50",
"PackageDescription": "50 mL in 1 TUBE (83021-305-50) ",
"NDC11Code": "83021-0305-50",
"ProductNDC": "83021-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Spa Line",
"NonProprietaryName": "Oryza Sativa (rice) Starch, Perlite, Palmitic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221014",
"EndMarketingDate": "20271013",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "FRAGRANCE 13576; GRAPE SEED OIL; GLYCERYL MONOSTEARATE; LINALOOL, (+/-)-; PHENOXYETHANOL; PROPYLENE GLYCOL; TITANIUM DIOXIDE; PALMITIC ACID; BUTYLATED HYDROXYTOLUENE; STARCH, RICE; ALCOHOL; C12-20 ACID PEG-8 ESTER; TROLAMINE; ISOMETHYL-.ALPHA.-IONONE; HYDROXYACETOPHENONE; PERLITE; GLYCERIN; ETHYLHEXYLGLYCERIN; .BETA.-CITRONELLOL, (R)-; WATER; STEARIC ACID; CETEARYL ETHYLHEXANOATE",
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"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20271013",
"SamplePackage": "N"
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{
"NDCCode": "83021-495-20",
"PackageDescription": "20 mL in 1 BOTTLE, DROPPER (83021-495-20) ",
"NDC11Code": "83021-0495-20",
"ProductNDC": "83021-495",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Proteoglycan, Glycerin, Butylene Glycol",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221025",
"EndMarketingDate": "20270902",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "PHENOXYETHANOL; XANTHAN GUM; BENZOIC ACID; WATER; BUTYLENE GLYCOL; PROPANEDIOL; POLYSORBATE 20; EDETIC ACID; PROTEOGLYCAN 4; FRAGRANCE 13576; GLYCERIN; DEHYDROACETIC ACID",
"StrengthNumber": ".162; .08; .024; 16.4578; .46; .4; .2; .0002; .002; .03; 2; .014",
"StrengthUnit": "g/20mL; g/20mL; g/20mL; mL/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL",
"Pharm_Classes": "Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221025",
"EndMarketingDatePackage": "20270902",
"SamplePackage": "N"
},
{
"NDCCode": "83021-501-20",
"PackageDescription": "20 mL in 1 BOTTLE, DROPPER (83021-501-20) ",
"NDC11Code": "83021-0501-20",
"ProductNDC": "83021-501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Ferulic Acid, Vitamin C, Dmae",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221013",
"EndMarketingDate": "20280124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "ALCOHOL; GLYCERIN; LECITHIN, SOYBEAN; WATER; MALONDIALDEHYDE; POLYOXYL 35 CASTOR OIL; FRAGRANCE 13576; PEG-8 CAPRYLIC/CAPRIC GLYCERIDES; FERULIC ACID",
"StrengthNumber": ".96; .02; .12; 14.26; 2; .18; .02; 2; .1",
"StrengthUnit": "mL/20mL; g/20mL; g/20mL; mL/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221013",
"EndMarketingDatePackage": "20280124",
"SamplePackage": "N"
},
{
"NDCCode": "83021-546-30",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (83021-546-30) ",
"NDC11Code": "83021-0546-30",
"ProductNDC": "83021-546",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Dmae",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230113",
"EndMarketingDate": "20270805",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "GLYCERIN; PHENOXYETHANOL; XANTHAN GUM; FRAGRANCE 13576; SORBITAN ISOSTEARATE; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); LIMONENE, (+)-; TOCOPHEROL; HYDROXYCITRONELLAL; POLYSORBATE 60; LECITHIN, SOYBEAN; HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%); DEHYDROACETIC ACID; PROPANEDIOL; DICAPRYLYL ETHER; BENZOIC ACID; ASCORBYL GLUCOSIDE; WATER",
"StrengthNumber": ".555; .243; .09; .027; .024; .0012; .0009; .0003; .0006; .024; .45; .405; .021; 1.08; .9; .036; .15; 25.5564",
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"LastUpdate": "2023-09-05",
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"EndMarketingDatePackage": "20270805",
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},
{
"NDCCode": "83021-553-60",
"PackageDescription": "60 mL in 1 JAR (83021-553-60) ",
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"ProductNDC": "83021-553",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Dmae, Zirhafirm",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230113",
"EndMarketingDate": "20280306",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "ALOE VERA LEAF; LINALOOL, (+/-)-; EUGENOL; PROPANEDIOL; BENZYL ALCOHOL; CETOSTEARYL ALCOHOL; DICAPRYLYL ETHER; SORBIC ACID; XANTHAN GUM; .BETA.-CITRONELLOL, (R)-; GLYCERYL MONOSTEARATE; FRAGRANCE 13576; SALICYLIC ACID; JUJUBE SEED; LECITHIN, SOYBEAN; BAICALIN; LEUZEA CARTHAMOIDES ROOT; WATER; LIMONENE, (+)-; HYDROXYCITRONELLAL; TOCOPHEROL; GLYCERIN; DECYL OLEATE; SHEA BUTTER",
"StrengthNumber": "5.988; .0006; .0006; 2.496; .456; 1.2; 1.5; .024; .18; .0006; 2.4; .114; .09; .048; .036; .012; .012; 33.2616; .006; .0024; .0018; 3.036; 3.9; 2.1",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Pediculicide [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20280306",
"SamplePackage": "N"
},
{
"NDCCode": "83021-624-10",
"PackageDescription": "10 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10) ",
"NDC11Code": "83021-0624-10",
"ProductNDC": "83021-624",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Regul Oil",
"NonProprietaryName": "Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Arctium Majus Root Extract",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221021",
"EndMarketingDate": "20270707",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "ALCOHOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; YEAST, UNSPECIFIED; PROPYLENE GLYCOL; ARCTIUM LAPPA ROOT; ALLANTOIN; POWDERED CELLULOSE; PROPYLPARABEN; TOCOPHEROL; FRAGRANCE 13576; ETHYLPARABEN; ASCORBYL PALMITATE; WATER; TIOXOLONE; LEVOMENOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ISOPROPYL ALCOHOL; FARNESOL; METHYLPARABEN; PANTHENOL; PHENOXYETHANOL; BUTYLPARABEN; NIACINAMIDE; RIBOFLAVIN; CITRAL; LIMONENE, (+)-; FD&C YELLOW NO. 5",
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"StrengthUnit": "mL/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; mL/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
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"LastUpdate": "2023-09-05",
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"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20270707",
"SamplePackage": "N"
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{
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"PackageDescription": "50 mL in 1 BOTTLE (83021-686-50) ",
"NDC11Code": "83021-0686-50",
"ProductNDC": "83021-686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Protective Line",
"NonProprietaryName": "Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221102",
"EndMarketingDate": "20280309",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "ANUBIS COSMETICS SL",
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"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221102",
"EndMarketingDatePackage": "20280309",
"SamplePackage": "N"
},
{
"NDCCode": "83021-692-01",
"PackageDescription": "250 mL in 1 BOTTLE, SPRAY (83021-692-01) ",
"NDC11Code": "83021-0692-01",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Total Hydrating",
"NonProprietaryName": "Betaine, Glycerin, Polysorbate 20",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221013",
"EndMarketingDate": "20270912",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "BETAINE; FRAGRANCE 13576; FD&C BLUE NO. 1; BENZOIC ACID; GLYCERIN; PHENOXYETHANOL; ETHYLHEXYLGLYCERIN; POLYSORBATE 20; WATER; IMIDUREA",
"StrengthNumber": "5; .125; .00025; 1.75; 5; 2.25; .125; 2.75; 232.139; .75",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Methylating Activity [MoA], Methylating Agent [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
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"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20270912",
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"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221021",
"EndMarketingDate": "20270922",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "ANUBIS COSMETICS SL",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221021",
"EndMarketingDatePackage": "20270922",
"SamplePackage": "N"
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{
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"PackageDescription": "200 mL in 1 TUBE (83021-742-01) ",
"NDC11Code": "83021-0742-01",
"ProductNDC": "83021-742",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona Regul Oil",
"NonProprietaryName": "Cetearyl Ethylhexanoate, Propylene Glycol, Glyceryl Stearate Se",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221019",
"EndMarketingDate": "20270220",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M006",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "GLYCERIN; GERANIOL; ISOPROPYL ALCOHOL; ALCOHOL; OXYBENZONE; PHENOXYETHANOL; TEA TREE OIL; IMIDUREA; WATER; GLYCERYL STEARATE SE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; TIOXOLONE; LINALOOL, (+/-)-; FD&C YELLOW NO. 5; BENZYL BENZOATE; PANTHENOL; COUMARIN; C12-20 ACID PEG-8 ESTER; ARCTIUM LAPPA ROOT; PROPYLPARABEN; CETYL ALCOHOL; YEAST, UNSPECIFIED; RIBOFLAVIN; PROPYLENE GLYCOL; CETEARYL ETHYLHEXANOATE; HYDROXYETHYL CELLULOSE, UNSPECIFIED; BUTYLATED HYDROXYTOLUENE; CITRAL; GREEN TEA LEAF; ALLANTOIN; LIMONENE, (+)-; NIACINAMIDE; POWDERED CELLULOSE; POLYOXYL 40 HYDROGENATED CASTOR OIL; .ALPHA.-HEXYLCINNAMALDEHYDE; OCTINOXATE; METHYLPARABEN; FRAGRANCE 13576",
"StrengthNumber": ".08784; .003398; .002132; 3.5436; 1.6; 1.3; .1; .4; 155.839258; 6; .8; .3; .026404; .01044; .004; .04; .003924; 4; .003512; .28; .015; .1; .00012; 6.469044; 10; .12863; .104; .01032; .00679; .2; .061818; .02; .001066; 1.8; .00574; 3.996; .6; .5",
"StrengthUnit": "g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221019",
"EndMarketingDatePackage": "20270220",
"SamplePackage": "N"
},
{
"NDCCode": "83021-750-50",
"PackageDescription": "50 mL in 1 JAR (83021-750-50) ",
"NDC11Code": "83021-0750-50",
"ProductNDC": "83021-750",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubismed",
"NonProprietaryName": "Ha Hyaluronic",
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"EndMarketingDate": "20280116",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "ALLANTOIN; ALOE VERA LEAF; FRAGRANCE 13576; GLYCERYL MONOSTEARATE; TROLAMINE; BUTYLATED HYDROXYTOLUENE; PROPYLENE GLYCOL; CETYL ALCOHOL; TROPOLONE; TOCOPHEROL; DIMETHICONE; 1,2-HEXANEDIOL; IMIDUREA; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; CETEARYL ETHYLHEXANOATE; MEDIUM-CHAIN TRIGLYCERIDES; CAPRYLYL GLYCOL; OCTINOXATE; GLYCERIN; GLYCERYL STEARATE SE; WATER; C12-20 ACID PEG-8 ESTER; OXYBENZONE; DECYL OLEATE",
"StrengthNumber": ".05; 2.5; .225; .875; .3; .0535; 1.996; .0038; .004; .0004; .25; .198; .15; .25; 1.75; 1.5; .198; 3.4965; .4975; 1.5; 27.4065; 2.25; 2; 1.9996",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Standardized Chemical Allergen [EPC]",
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"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
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},
{
"NDCCode": "83021-839-07",
"PackageDescription": "1.5 mL in 1 VIAL, SINGLE-USE (83021-839-07) ",
"NDC11Code": "83021-0839-07",
"ProductNDC": "83021-839",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Propanediol, Glycerin, Magnesium Ascorbyl Phosphate",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221018",
"EndMarketingDate": "20270113",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "GLYCERIN; PHENOXYETHANOL; FRAGRANCE 13576; DEHYDROACETIC ACID; WATER; PEG-8 CAPRYLIC/CAPRIC GLYCERIDES; ISOMETHYL-.ALPHA.-IONONE; EDETIC ACID; BENZOIC ACID; SORBIC ACID; BENZYL ALCOHOL; PROPANEDIOL; HYDROXYCITRONELLAL",
"StrengthNumber": ".01035; .0003; .00285; .00135; 1.16659425; .15; .00003; .000009; .0009; .0006; .01215; .15; .00006",
"StrengthUnit": "g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; mL/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Pediculicide [EPC], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221018",
"EndMarketingDatePackage": "20270113",
"SamplePackage": "N"
},
{
"NDCCode": "83021-877-07",
"PackageDescription": "1.5 mL in 1 VIAL, SINGLE-USE (83021-877-07) ",
"NDC11Code": "83021-0877-07",
"ProductNDC": "83021-877",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anubis Barcelona",
"NonProprietaryName": "Glycerin, Sorbitol, Aloe Barbadensis Leaf Juice",
"DosageFormName": "CONCENTRATE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221019",
"EndMarketingDate": "20270114",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M016",
"LabelerName": "ANUBIS COSMETICS SL",
"SubstanceName": "SORBITOL; SACCHAROMYCES LYSATE; WATER; 1,2-HEXANEDIOL; GLYCERIN; LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE; HYALURONATE SODIUM; FD&C BLUE NO. 1; PHENOXYETHANOL; ALOE VERA LEAF; ETHYLHEXYLGLYCERIN",
"StrengthNumber": ".0525; .00075; 1.219341; .0165; .16875; .000015; .0075; .000009; .0141; .008955; .0015",
"StrengthUnit": "g/1.5mL; g/1.5mL; mL/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230221",
"EndMarketingDatePackage": "20270114",
"SamplePackage": "N"
},
{
"NDCCode": "42002-617-01",
"PackageDescription": "1 TUBE in 1 CARTON (42002-617-01) > 74 g in 1 TUBE",
"NDC11Code": "42002-0617-01",
"ProductNDC": "42002-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rembrandt Deeply White Plus Peroxide Whitening",
"ProprietaryNameSuffix": "Fresh Mint",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20120316",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-05-09",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43269-617-02",
"PackageDescription": "59 mL in 1 CONTAINER (43269-617-02)",
"NDC11Code": "43269-0617-02",
"ProductNDC": "43269-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Papaya Mango Antibacterial Hand",
"NonProprietaryName": "Alcohol, Denatured",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100611",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-03-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43547-617-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-617-03) ",
"NDC11Code": "43547-0617-03",
"ProductNDC": "43547-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217368",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220705",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate tablets are a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3‑ [(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate, USP, has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Crospovidone, Dicalcium Phosphate Anhydrous, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Pregelatinized Starch. The coating materials for all strengths contain Macrogol/PEG, Polyvinyl Alcohol-part hydrolyzed, Talc, Titanium Dioxide. The 5 mg tablets also contain Red Iron Oxide. FDA approved dissolution test specifications differ from USP."
}
]
}
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<NDCList>
<NDC>
<NDCCode>83021-617-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, GLASS (83021-617-05) </PackageDescription>
<NDC11Code>83021-0617-05</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Allantoin</NonProprietaryName>
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<EndMarketingDate>20270920</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>PROPYLPARABEN; ALLANTOIN; PANTHENOL; FD&C YELLOW NO. 5; PROPYLENE GLYCOL; ARCTIUM LAPPA ROOT; METHYLPARABEN; TIOXOLONE; WATER; ALCOHOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; YEAST, UNSPECIFIED; ASCORBYL PALMITATE; RIBOFLAVIN; ETHYLPARABEN; TOCOPHEROL; CITRAL; LIMONENE, (+)-; POWDERED CELLULOSE; ISOPROPYL ALCOHOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; LEVOMENOL; FARNESOL; FRAGRANCE 13576; PHENOXYETHANOL; BUTYLPARABEN; NIACINAMIDE</SubstanceName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221021</StartMarketingDatePackage>
<EndMarketingDatePackage>20270920</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-617-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (31722-617-05) </PackageDescription>
<NDC11Code>31722-0617-05</NDC11Code>
<ProductNDC>31722-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206912</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42192-617-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (42192-617-05) </PackageDescription>
<NDC11Code>42192-0617-05</NDC11Code>
<ProductNDC>42192-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210802</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091310</ApplicationNumber>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate; with a molecular weight of 603.0. Each benzonatate capsule USP, 100 mg contains: Benzonatate, USP 100 mg. Each benzonatate capsule USP, 200 mg contains: Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: gelatin 175 bloom bone NF, glycerin 99% USP, methyl/propyl paraben blend (4:1 ), yellow #10-DC and white ink (shellac glaze in SD-45, titanium dioxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and simethicone).</Description>
</NDC>
<NDC>
<NDCCode>50742-617-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-617-05) </PackageDescription>
<NDC11Code>50742-0617-05</NDC11Code>
<ProductNDC>50742-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204106</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>53666-617-01</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX (53666-617-01) > .05 g in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53666-0617-01</NDC11Code>
<ProductNDC>53666-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Desenfriol-d</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Salimex, S.A.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>.002; .005; .5</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies:. headache. sinus congestion and pressure. nasal congestion. runny nose and sneezing. minor aches and pains. temporarily relieves these additional symptoms of hay fever:. itching of the nose or throat. itchy, watery eyes. helps clear nasal passages. helps decongest sinus openings and passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53746-617-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (53746-617-05) </PackageDescription>
<NDC11Code>53746-0617-05</NDC11Code>
<ProductNDC>53746-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090485</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-617-05</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE (55111-617-05) </PackageDescription>
<NDC11Code>55111-0617-05</NDC11Code>
<ProductNDC>55111-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091024</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets are administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its molecular formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:. Eszopiclone USP is a white to slightly yellowish powder. Eszopiclone is soluble in methylene chloride, practically insoluble in water and alcohol. It dissolves in dilute mineral acids. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcelac 100 (lactose monohydrate and cellulose, microcrystalline), polyethylene glycol and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2 and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>58602-617-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58602-617-05) / 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58602-0617-05</NDC11Code>
<ProductNDC>58602-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dextromethorphan Polistirex</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218417</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>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>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65841-617-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65841-617-05) </PackageDescription>
<NDC11Code>65841-0617-05</NDC11Code>
<ProductNDC>65841-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077614</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-617-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-617-05) </PackageDescription>
<NDC11Code>68428-0617-05</NDC11Code>
<ProductNDC>68428-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salvia Officinalis</ProprietaryName>
<NonProprietaryName>Sage</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091016</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SAGE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75839-617-05</NDCCode>
<PackageDescription>.5 kg in 1 CONTAINER (75839-617-05)</PackageDescription>
<NDC11Code>75839-0617-05</NDC11Code>
<ProductNDC>75839-617</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dexamethasone Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161014</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>DEXAMETHASONE ACETATE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>83021-033-01</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, SPRAY (83021-033-01) </PackageDescription>
<NDC11Code>83021-0033-01</NDC11Code>
<ProductNDC>83021-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona New Even</ProprietaryName>
<NonProprietaryName>Lactic Acid, Citric Acid, Glycolic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221013</StartMarketingDate>
<EndMarketingDate>20270113</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>FD&C BLUE NO. 1; LACTIC ACID; POLYOXYL 40 HYDROGENATED CASTOR OIL; TROLAMINE; .ALPHA.-HEXYLCINNAMALDEHYDE; LINALOOL, (+/-)-; BENZOIC ACID; PHENOXYETHANOL; GLYCOLIC ACID; WATER; ALLANTOIN; DEHYDROACETIC ACID; DIETHYLENE GLYCOL MONOETHYL ETHER; FRAGRANCE 13576; LIMONENE, (+)-; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.0005; 2.348125; 1.25; .5; .0150375; .0041025; .625; 2.5; 1.220625; 228.15635; .75; .25; .75; .075; .022755; 10.5</StrengthNumber>
<StrengthUnit>g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; mL/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221013</StartMarketingDatePackage>
<EndMarketingDatePackage>20270113</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-187-01</NDCCode>
<PackageDescription>200 mL in 1 TUBE (83021-187-01) </PackageDescription>
<NDC11Code>83021-0187-01</NDC11Code>
<ProductNDC>83021-187</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Vital Line</ProprietaryName>
<NonProprietaryName>Hydrolyzed Elastin, Hydrolysed Collagen, Cocoglycerides</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221025</StartMarketingDate>
<EndMarketingDate>20261020</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>AVOBENZONE; PHENOXYETHANOL; FRAGRANCE 13576; DEHYDROACETIC ACID; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); OCTINOXATE; COCO-GLYCERIDES; GLYCERIN; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); CETOSTEARYL ALCOHOL; MEDIUM-CHAIN TRIGLYCERIDES; CETYL ALCOHOL; .ALPHA.-HEXYLCINNAMALDEHYDE; WATER; BENZOIC ACID; CENTAUREA CYANUS FLOWER; VIOLA ODORATA; LIMONENE, (+)-; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; .BETA.-CITRONELLOL, (R)-; ISOMETHYL-.ALPHA.-IONONE; BUTYLATED HYDROXYTOLUENE</SubstanceName>
<StrengthNumber>2; 1.62; .98; .14; .03; 5; 8; 6.94; .6; 12.58; 12; 4; .16; 140; .24; .05; .05; .038; .006; .0056; .0054; .005</StrengthNumber>
<StrengthUnit>g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221025</StartMarketingDatePackage>
<EndMarketingDatePackage>20261020</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-300-01</NDCCode>
<PackageDescription>200 mL in 1 TUBE (83021-300-01) </PackageDescription>
<NDC11Code>83021-0300-01</NDC11Code>
<ProductNDC>83021-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Regul Oil</ProprietaryName>
<NonProprietaryName>Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (hops) Cone Extract</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221020</StartMarketingDate>
<EndMarketingDate>20280203</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>ARCTIUM LAPPA ROOT; POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE); LAURETH-7; PEG/PPG-20/6 DIMETHICONE; ALCOHOL; GLYCERIN; CETEARYL ETHYLHEXANOATE; LIMONENE, (+)-; PANTHENOL; IMIDUREA; FD&C YELLOW NO. 5; RIBOFLAVIN; PHENOXYETHANOL; FRAGRANCE 13576; WATER; CETOSTEARYL ALCOHOL; PROPYLENE GLYCOL; MINERAL OIL; ETHYLHEXYLGLYCERIN; METHYLCHLOROISOTHIAZOLINONE; METHYLISOTHIAZOLINONE; HOPS; TIOXOLONE; PROPYLPARABEN; YEAST, UNSPECIFIED; NIACINAMIDE; C13-14 ISOPARAFFIN; METHYLPARABEN; GLYCERYL STEARATE SE; TRIISOPROPANOLAMINE; PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)</SubstanceName>
<StrengthNumber>.012; .8; .12; 1.372; .08; .048; 4; .08398; .1; .6; .00004; .00012; .0252; .6; 123.55598; 26; 10.148; 6; .0028; .045; .15; .0012; .3; .24; .023; .023; .48; .48; 7; .004; .0012</StrengthNumber>
<StrengthUnit>g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221020</StartMarketingDatePackage>
<EndMarketingDatePackage>20280203</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-305-50</NDCCode>
<PackageDescription>50 mL in 1 TUBE (83021-305-50) </PackageDescription>
<NDC11Code>83021-0305-50</NDC11Code>
<ProductNDC>83021-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Spa Line</ProprietaryName>
<NonProprietaryName>Oryza Sativa (rice) Starch, Perlite, Palmitic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221014</StartMarketingDate>
<EndMarketingDate>20271013</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>FRAGRANCE 13576; GRAPE SEED OIL; GLYCERYL MONOSTEARATE; LINALOOL, (+/-)-; PHENOXYETHANOL; PROPYLENE GLYCOL; TITANIUM DIOXIDE; PALMITIC ACID; BUTYLATED HYDROXYTOLUENE; STARCH, RICE; ALCOHOL; C12-20 ACID PEG-8 ESTER; TROLAMINE; ISOMETHYL-.ALPHA.-IONONE; HYDROXYACETOPHENONE; PERLITE; GLYCERIN; ETHYLHEXYLGLYCERIN; .BETA.-CITRONELLOL, (R)-; WATER; STEARIC ACID; CETEARYL ETHYLHEXANOATE</SubstanceName>
<StrengthNumber>.15; .25; 3.5; .0114; .45; 1.5; .25; 1; .25; 5.5; 4.752; 1; .25; .00639; .25; 4; .0115; .05; .012; 25.04945; 1; .75</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221014</StartMarketingDatePackage>
<EndMarketingDatePackage>20271013</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-495-20</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, DROPPER (83021-495-20) </PackageDescription>
<NDC11Code>83021-0495-20</NDC11Code>
<ProductNDC>83021-495</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Proteoglycan, Glycerin, Butylene Glycol</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221025</StartMarketingDate>
<EndMarketingDate>20270902</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>PHENOXYETHANOL; XANTHAN GUM; BENZOIC ACID; WATER; BUTYLENE GLYCOL; PROPANEDIOL; POLYSORBATE 20; EDETIC ACID; PROTEOGLYCAN 4; FRAGRANCE 13576; GLYCERIN; DEHYDROACETIC ACID</SubstanceName>
<StrengthNumber>.162; .08; .024; 16.4578; .46; .4; .2; .0002; .002; .03; 2; .014</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL; g/20mL; mL/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221025</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>20 mL in 1 BOTTLE, DROPPER (83021-501-20) </PackageDescription>
<NDC11Code>83021-0501-20</NDC11Code>
<ProductNDC>83021-501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Ferulic Acid, Vitamin C, Dmae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<EndMarketingDate>20280124</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>ALCOHOL; GLYCERIN; LECITHIN, SOYBEAN; WATER; MALONDIALDEHYDE; POLYOXYL 35 CASTOR OIL; FRAGRANCE 13576; PEG-8 CAPRYLIC/CAPRIC GLYCERIDES; FERULIC ACID</SubstanceName>
<StrengthNumber>.96; .02; .12; 14.26; 2; .18; .02; 2; .1</StrengthNumber>
<StrengthUnit>mL/20mL; g/20mL; g/20mL; mL/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221013</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>30 mL in 1 BOTTLE, DROPPER (83021-546-30) </PackageDescription>
<NDC11Code>83021-0546-30</NDC11Code>
<ProductNDC>83021-546</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Dmae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
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<EndMarketingDate>20270805</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>GLYCERIN; PHENOXYETHANOL; XANTHAN GUM; FRAGRANCE 13576; SORBITAN ISOSTEARATE; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); LIMONENE, (+)-; TOCOPHEROL; HYDROXYCITRONELLAL; POLYSORBATE 60; LECITHIN, SOYBEAN; HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%); DEHYDROACETIC ACID; PROPANEDIOL; DICAPRYLYL ETHER; BENZOIC ACID; ASCORBYL GLUCOSIDE; WATER</SubstanceName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<NDC11Code>83021-0553-60</NDC11Code>
<ProductNDC>83021-553</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Dmae, Zirhafirm</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<EndMarketingDate>20280306</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>ALOE VERA LEAF; LINALOOL, (+/-)-; EUGENOL; PROPANEDIOL; BENZYL ALCOHOL; CETOSTEARYL ALCOHOL; DICAPRYLYL ETHER; SORBIC ACID; XANTHAN GUM; .BETA.-CITRONELLOL, (R)-; GLYCERYL MONOSTEARATE; FRAGRANCE 13576; SALICYLIC ACID; JUJUBE SEED; LECITHIN, SOYBEAN; BAICALIN; LEUZEA CARTHAMOIDES ROOT; WATER; LIMONENE, (+)-; HYDROXYCITRONELLAL; TOCOPHEROL; GLYCERIN; DECYL OLEATE; SHEA BUTTER</SubstanceName>
<StrengthNumber>5.988; .0006; .0006; 2.496; .456; 1.2; 1.5; .024; .18; .0006; 2.4; .114; .09; .048; .036; .012; .012; 33.2616; .006; .0024; .0018; 3.036; 3.9; 2.1</StrengthNumber>
<StrengthUnit>g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; mL/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Pediculicide [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230113</StartMarketingDatePackage>
<EndMarketingDatePackage>20280306</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-624-10</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10) </PackageDescription>
<NDC11Code>83021-0624-10</NDC11Code>
<ProductNDC>83021-624</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Regul Oil</ProprietaryName>
<NonProprietaryName>Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Arctium Majus Root Extract</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<EndMarketingDate>20270707</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>ALCOHOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; YEAST, UNSPECIFIED; PROPYLENE GLYCOL; ARCTIUM LAPPA ROOT; ALLANTOIN; POWDERED CELLULOSE; PROPYLPARABEN; TOCOPHEROL; FRAGRANCE 13576; ETHYLPARABEN; ASCORBYL PALMITATE; WATER; TIOXOLONE; LEVOMENOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ISOPROPYL ALCOHOL; FARNESOL; METHYLPARABEN; PANTHENOL; PHENOXYETHANOL; BUTYLPARABEN; NIACINAMIDE; RIBOFLAVIN; CITRAL; LIMONENE, (+)-; FD&C YELLOW NO. 5</SubstanceName>
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<StrengthUnit>mL/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; mL/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221021</StartMarketingDatePackage>
<EndMarketingDatePackage>20270707</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-686-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (83021-686-50) </PackageDescription>
<NDC11Code>83021-0686-50</NDC11Code>
<ProductNDC>83021-686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Protective Line</ProprietaryName>
<NonProprietaryName>Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221102</StartMarketingDate>
<EndMarketingDate>20280309</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; CHLORPHENESIN; OCTISALATE; BUTYLENE GLYCOL; PROPYLENE GLYCOL; POLY(METHYL METHACRYLATE; 450000 MW); WATER; SILICON DIOXIDE; BUTYLATED HYDROXYTOLUENE; DIMETHICONE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; C20-22 ALCOHOLS; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); TROMETHAMINE; BEMOTRIZINOL; POLYETHYLENE GLYCOL 400; ASCORBYL PALMITATE; PHENOXYETHANOL; OCTOCRYLENE; AVOBENZONE; LINOLENIC ACID; ASCORBIC ACID; TOCOPHEROL; LINOLEIC ACID; GLYCERIN</SubstanceName>
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<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221102</StartMarketingDatePackage>
<EndMarketingDatePackage>20280309</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>250 mL in 1 BOTTLE, SPRAY (83021-692-01) </PackageDescription>
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<ProductNDC>83021-692</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Total Hydrating</ProprietaryName>
<NonProprietaryName>Betaine, Glycerin, Polysorbate 20</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221013</StartMarketingDate>
<EndMarketingDate>20270912</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>BETAINE; FRAGRANCE 13576; FD&C BLUE NO. 1; BENZOIC ACID; GLYCERIN; PHENOXYETHANOL; ETHYLHEXYLGLYCERIN; POLYSORBATE 20; WATER; IMIDUREA</SubstanceName>
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<StrengthUnit>g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; mL/250mL; g/250mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Methylating Activity [MoA], Methylating Agent [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221013</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-740-01</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, SPRAY (83021-740-01) </PackageDescription>
<NDC11Code>83021-0740-01</NDC11Code>
<ProductNDC>83021-740</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona Regul Oil</ProprietaryName>
<NonProprietaryName>Propylene Glycol, Panthenol, Thiamine Hcl</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221021</StartMarketingDate>
<EndMarketingDate>20270922</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>ALCOHOL; NIACINAMIDE; TIOXOLONE; ARCTIUM LAPPA ROOT; RIBOFLAVIN; POLYOXYL 40 HYDROGENATED CASTOR OIL; METHYLPARABEN; YEAST, UNSPECIFIED; FD&C YELLOW NO. 5; GLYCERIN; FRAGRANCE 13576; WATER; PANTHENOL; LIMONENE, (+)-; ALLANTOIN; CITRAL; PROPYLENE GLYCOL</SubstanceName>
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<StrengthUnit>mL/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; mL/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221021</StartMarketingDatePackage>
<EndMarketingDatePackage>20270922</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>83021-742-01</NDCCode>
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<ProductNDC>83021-742</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221019</StartMarketingDate>
<EndMarketingDate>20270220</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>GLYCERIN; GERANIOL; ISOPROPYL ALCOHOL; ALCOHOL; OXYBENZONE; PHENOXYETHANOL; TEA TREE OIL; IMIDUREA; WATER; GLYCERYL STEARATE SE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; TIOXOLONE; LINALOOL, (+/-)-; FD&C YELLOW NO. 5; BENZYL BENZOATE; PANTHENOL; COUMARIN; C12-20 ACID PEG-8 ESTER; ARCTIUM LAPPA ROOT; PROPYLPARABEN; CETYL ALCOHOL; YEAST, UNSPECIFIED; RIBOFLAVIN; PROPYLENE GLYCOL; CETEARYL ETHYLHEXANOATE; HYDROXYETHYL CELLULOSE, UNSPECIFIED; BUTYLATED HYDROXYTOLUENE; CITRAL; GREEN TEA LEAF; ALLANTOIN; LIMONENE, (+)-; NIACINAMIDE; POWDERED CELLULOSE; POLYOXYL 40 HYDROGENATED CASTOR OIL; .ALPHA.-HEXYLCINNAMALDEHYDE; OCTINOXATE; METHYLPARABEN; FRAGRANCE 13576</SubstanceName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221019</StartMarketingDatePackage>
<EndMarketingDatePackage>20270220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<NDC11Code>83021-0750-50</NDC11Code>
<ProductNDC>83021-750</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubismed</ProprietaryName>
<NonProprietaryName>Ha Hyaluronic</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221017</StartMarketingDate>
<EndMarketingDate>20280116</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>ALLANTOIN; ALOE VERA LEAF; FRAGRANCE 13576; GLYCERYL MONOSTEARATE; TROLAMINE; BUTYLATED HYDROXYTOLUENE; PROPYLENE GLYCOL; CETYL ALCOHOL; TROPOLONE; TOCOPHEROL; DIMETHICONE; 1,2-HEXANEDIOL; IMIDUREA; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; CETEARYL ETHYLHEXANOATE; MEDIUM-CHAIN TRIGLYCERIDES; CAPRYLYL GLYCOL; OCTINOXATE; GLYCERIN; GLYCERYL STEARATE SE; WATER; C12-20 ACID PEG-8 ESTER; OXYBENZONE; DECYL OLEATE</SubstanceName>
<StrengthNumber>.05; 2.5; .225; .875; .3; .0535; 1.996; .0038; .004; .0004; .25; .198; .15; .25; 1.75; 1.5; .198; 3.4965; .4975; 1.5; 27.4065; 2.25; 2; 1.9996</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221017</StartMarketingDatePackage>
<EndMarketingDatePackage>20280116</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-839-07</NDCCode>
<PackageDescription>1.5 mL in 1 VIAL, SINGLE-USE (83021-839-07) </PackageDescription>
<NDC11Code>83021-0839-07</NDC11Code>
<ProductNDC>83021-839</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Propanediol, Glycerin, Magnesium Ascorbyl Phosphate</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221018</StartMarketingDate>
<EndMarketingDate>20270113</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>GLYCERIN; PHENOXYETHANOL; FRAGRANCE 13576; DEHYDROACETIC ACID; WATER; PEG-8 CAPRYLIC/CAPRIC GLYCERIDES; ISOMETHYL-.ALPHA.-IONONE; EDETIC ACID; BENZOIC ACID; SORBIC ACID; BENZYL ALCOHOL; PROPANEDIOL; HYDROXYCITRONELLAL</SubstanceName>
<StrengthNumber>.01035; .0003; .00285; .00135; 1.16659425; .15; .00003; .000009; .0009; .0006; .01215; .15; .00006</StrengthNumber>
<StrengthUnit>g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; mL/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Pediculicide [EPC], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221018</StartMarketingDatePackage>
<EndMarketingDatePackage>20270113</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83021-877-07</NDCCode>
<PackageDescription>1.5 mL in 1 VIAL, SINGLE-USE (83021-877-07) </PackageDescription>
<NDC11Code>83021-0877-07</NDC11Code>
<ProductNDC>83021-877</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anubis Barcelona</ProprietaryName>
<NonProprietaryName>Glycerin, Sorbitol, Aloe Barbadensis Leaf Juice</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221019</StartMarketingDate>
<EndMarketingDate>20270114</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>ANUBIS COSMETICS SL</LabelerName>
<SubstanceName>SORBITOL; SACCHAROMYCES LYSATE; WATER; 1,2-HEXANEDIOL; GLYCERIN; LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE; HYALURONATE SODIUM; FD&C BLUE NO. 1; PHENOXYETHANOL; ALOE VERA LEAF; ETHYLHEXYLGLYCERIN</SubstanceName>
<StrengthNumber>.0525; .00075; 1.219341; .0165; .16875; .000015; .0075; .000009; .0141; .008955; .0015</StrengthNumber>
<StrengthUnit>g/1.5mL; g/1.5mL; mL/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<EndMarketingDatePackage>20270114</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42002-617-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42002-617-01) > 74 g in 1 TUBE</PackageDescription>
<NDC11Code>42002-0617-01</NDC11Code>
<ProductNDC>42002-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rembrandt Deeply White Plus Peroxide Whitening</ProprietaryName>
<ProprietaryNameSuffix>Fresh Mint</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-09</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43269-617-02</NDCCode>
<PackageDescription>59 mL in 1 CONTAINER (43269-617-02)</PackageDescription>
<NDC11Code>43269-0617-02</NDC11Code>
<ProductNDC>43269-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Papaya Mango Antibacterial Hand</ProprietaryName>
<NonProprietaryName>Alcohol, Denatured</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100611</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43547-617-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-617-03) </PackageDescription>
<NDC11Code>43547-0617-03</NDC11Code>
<ProductNDC>43547-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217368</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate tablets are a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3‑ [(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate, USP, has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Crospovidone, Dicalcium Phosphate Anhydrous, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Pregelatinized Starch. The coating materials for all strengths contain Macrogol/PEG, Polyvinyl Alcohol-part hydrolyzed, Talc, Titanium Dioxide. The 5 mg tablets also contain Red Iron Oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>