{
"NDC": [
{
"NDCCode": "52565-045-99",
"PackageDescription": "1 TUBE in 1 CARTON (52565-045-99) > 100 g in 1 TUBE",
"NDC11Code": "52565-0045-99",
"ProductNDC": "52565-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209973",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "52565-030-99",
"PackageDescription": "1 TUBE in 1 CARTON (52565-030-99) > 100 g in 1 TUBE",
"NDC11Code": "52565-0030-99",
"ProductNDC": "52565-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208101",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160225",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "52565-045-15",
"PackageDescription": "1 TUBE in 1 CARTON (52565-045-15) > 15 g in 1 TUBE",
"NDC11Code": "52565-0045-15",
"ProductNDC": "52565-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209973",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "52565-045-30",
"PackageDescription": "1 TUBE in 1 CARTON (52565-045-30) > 30 g in 1 TUBE",
"NDC11Code": "52565-0045-30",
"ProductNDC": "52565-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209973",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "52565-045-60",
"PackageDescription": "1 TUBE in 1 CARTON (52565-045-60) > 60 g in 1 TUBE",
"NDC11Code": "52565-0045-60",
"ProductNDC": "52565-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209973",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "13107-045-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (13107-045-99) ",
"NDC11Code": "13107-0045-99",
"ProductNDC": "13107-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201972",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130715",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone 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": "Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "59779-045-99",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (59779-045-99) ",
"NDC11Code": "59779-0045-99",
"ProductNDC": "59779-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Witch Hazel",
"NonProprietaryName": "Witch Hazel",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110404",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "WITCH HAZEL",
"StrengthNumber": "860",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110404",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of minor skin irritations due to: 1 insect bites, 2 minor cuts, 3 minor scrapes."
},
{
"NDCCode": "65862-045-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65862-045-99) ",
"NDC11Code": "65862-0045-99",
"ProductNDC": "65862-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077606",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060314",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using Lisinopril and Hydrochlorothiazide Tablets, USP consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering use of Lisinopril and Hydrochlorothiazide Tablets, USP it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema).",
"Description": "Lisinopril and Hydrochlorothiazide Tablets combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP; Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg containing 20 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP; and, Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg containing 20 mg lisinopril USP and 25 mg hydrochlorothiazide USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize starch) and starch. Lisinopril and hydrochlorothiazide 10 mg/12.5 mg and 20 mg/25 mg also contains ferric oxide red and ferric oxide yellow. Lisinopril and hydrochlorothiazide 20 mg/12.5 mg also contains ferric oxide yellow."
},
{
"NDCCode": "83012-045-99",
"PackageDescription": "20000 mL in 1 BAG (83012-045-99) ",
"NDC11Code": "83012-0045-99",
"ProductNDC": "83012-045",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Adalimumab",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240113",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Boehringer Ingelheim Fremont, Inc.",
"SubstanceName": "ADALIMUMAB-ADBM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2025-04-01",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "13-JAN-24"
},
{
"NDCCode": "49568-104-99",
"PackageDescription": "65 kg in 1 DRUM (49568-104-99) ",
"NDC11Code": "49568-0104-99",
"ProductNDC": "49568-104",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Livalo",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20100515",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Kowa Corporation Ltd.",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "1.045",
"StrengthUnit": "mg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-MAY-10"
},
{
"NDCCode": "53225-1070-1",
"PackageDescription": "99 g in 1 TUBE (53225-1070-1) ",
"NDC11Code": "53225-1070-01",
"ProductNDC": "53225-1070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona Gel",
"NonProprietaryName": "Lidocaine 4.5%, Diclofenac 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220502",
"EndMarketingDate": "20250301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Terrain Pharmaceuticals",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220502",
"EndMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.",
"Description": "Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Triethanolamine, Water."
},
{
"NDCCode": "57337-045-01",
"PackageDescription": "444 g in 1 BOTTLE (57337-045-01) ",
"NDC11Code": "57337-0045-01",
"ProductNDC": "57337-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xtracare Foam Antibacterial Hand Wash",
"ProprietaryNameSuffix": "Refill Vanilla Passion Flower",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140124",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Rejoice International",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "g/444g",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140124",
"SamplePackage": "N",
"IndicationAndUsage": "XtraCare® Foam Antibacterial HAnd Wash. Kills 99.9% of bacteria. Refill. Compare to Lysol foam antibacterial hand wash. vanilla passion flower. 15 Fl Oz (444mL)."
},
{
"NDCCode": "58503-045-01",
"PackageDescription": "444 g in 1 BOTTLE (58503-045-01) ",
"NDC11Code": "58503-0045-01",
"ProductNDC": "58503-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xtracare Foam Antibacterial Hand Wash",
"ProprietaryNameSuffix": "Refill Vanilla Passion Flower",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140124",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "China Ningbo Shangge Cosmetic Technology Corp",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "g/444g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140124",
"SamplePackage": "N",
"IndicationAndUsage": "XtraCare® Foam Antibacterial HAnd Wash. Kills 99.9% of bacteria. Refill. Compare to Lysol foam antibacterial hand wash. vanilla passion flower. 15 Fl Oz (444mL)."
},
{
"NDCCode": "68788-4013-9",
"PackageDescription": "99 g in 1 TUBE (68788-4013-9) ",
"NDC11Code": "68788-4013-09",
"ProductNDC": "68788-4013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona",
"NonProprietaryName": "Lidocaine 4.5%, Diclofenac 1%",
"DosageFormName": "GEL",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20250905",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250905",
"SamplePackage": "N",
"IndicationAndUsage": "Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.",
"Description": "Diclona is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water."
},
{
"NDCCode": "72189-688-35",
"PackageDescription": "99 g in 1 TUBE (72189-688-35) ",
"NDC11Code": "72189-0688-35",
"ProductNDC": "72189-688",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona Gel",
"NonProprietaryName": "Diclona Gel",
"DosageFormName": "GEL",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20260909",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Direct_Rx",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260909",
"SamplePackage": "N",
"IndicationAndUsage": "Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.",
"Description": "Diclona is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water."
},
{
"NDCCode": "72197-045-06",
"PackageDescription": "170 g in 1 JAR (72197-045-06) ",
"NDC11Code": "72197-0045-06",
"ProductNDC": "72197-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pharmacys Prescription Petroleum Jelly",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210616",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "American Consumer Products Corp",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "99.9",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210616",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily protects minor: cuts, scrapes, burns Temporarily protects and helps relieve chapped or cracked skin and lips Helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "76420-539-99",
"PackageDescription": "99 g in 1 TUBE (76420-539-99) ",
"NDC11Code": "76420-0539-99",
"ProductNDC": "76420-539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona Gel",
"NonProprietaryName": "Lidocaine 4.5%, Diclofenac 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240103",
"EndMarketingDate": "20250301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240103",
"EndMarketingDatePackage": "20250301",
"SamplePackage": "N"
},
{
"NDCCode": "80425-0250-1",
"PackageDescription": "99 g in 1 TUBE (80425-0250-1) ",
"NDC11Code": "80425-0250-01",
"ProductNDC": "80425-0250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona Gel",
"NonProprietaryName": "Lidocaine Hcl And Diclofenac Sodium",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Rx Pharmacy of Tennessee, LLC",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230110",
"SamplePackage": "N",
"IndicationAndUsage": "Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.",
"Description": "Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Triethanolamine, Water."
},
{
"NDCCode": "80425-0517-1",
"PackageDescription": "99 g in 1 TUBE (80425-0517-1) ",
"NDC11Code": "80425-0517-01",
"ProductNDC": "80425-0517",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona",
"NonProprietaryName": "Lidocaine 4.5%, Diclofenac 1%",
"DosageFormName": "GEL",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20250505",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Rx of Tennessee, LLC",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250505",
"SamplePackage": "N",
"IndicationAndUsage": "Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.",
"Description": "Diclonais comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water."
},
{
"NDCCode": "81968-045-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "81968-0045-14",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240918",
"SamplePackage": "Y",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "81968-045-30",
"PackageDescription": "30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) ",
"NDC11Code": "81968-0045-30",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220818",
"SamplePackage": "N",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "81968-045-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "81968-0045-31",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240510",
"EndMarketingDatePackage": "20270328",
"SamplePackage": "Y",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "81968-045-60",
"PackageDescription": "60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) ",
"NDC11Code": "81968-0045-60",
"ProductNDC": "81968-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvelity",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Bupropion Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215430",
"LabelerName": "Axsome Therapeutics, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE",
"StrengthNumber": "45; 105",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240628",
"SamplePackage": "N",
"Description": "AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "83881-102-35",
"PackageDescription": "99 g in 1 TUBE (83881-102-35) ",
"NDC11Code": "83881-0102-35",
"ProductNDC": "83881-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclona",
"NonProprietaryName": "Lidocaine 4.5%, Diclofenac 1%",
"DosageFormName": "GEL",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20250415",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Clinic Pharma",
"SubstanceName": "DICLOFENAC SODIUM; LIDOCAINE",
"StrengthNumber": ".01; .045",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250415",
"SamplePackage": "N",
"IndicationAndUsage": "Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.",
"Description": "Diclona is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water."
},
{
"NDCCode": "84507-045-01",
"PackageDescription": "30 g in 1 BOX (84507-045-01) ",
"NDC11Code": "84507-0045-01",
"ProductNDC": "84507-045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rigboo 12% Gel Azelaic Acid Acne",
"NonProprietaryName": "Acne Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250704",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Guangdong Miaolian Cosmetics Co., Ltd.",
"SubstanceName": "CENTELLA ASIATICA LEAF; SALICYLIC ACID; AZELAIC ACID; QUATERNIUM-73",
"StrengthNumber": ".002; .99; .003; .07",
"StrengthUnit": "mg/100g; mg/100g; mg/100g; mg/100g",
"Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250704",
"SamplePackage": "N",
"IndicationAndUsage": "clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer one or three times daily."
},
{
"NDCCode": "52565-002-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (52565-002-05) > 150 mL in 1 BOTTLE",
"NDC11Code": "52565-0002-05",
"ProductNDC": "52565-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202769",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
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"LastUpdate": "2023-08-02",
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"IndicationAndUsage": "Diclofenac Sodium Topical Solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).",
"Description": "Diclofenac Sodium Topical Solution USP, 1.5% is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application. Diclofenac Sodium Topical Solution USP, 1.5% contains 1.5% w/w diclofenac sodium, a benzene acetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzene acetic acid, monosodium salt. It is a white or slightly yellowish crystalline powder, slightly hygroscopic, and odorless that is freely soluble in methanol, soluble in alcohol, slightly soluble in acetone and sparingly soluble in water. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. The inactive ingredients in Diclofenac Sodium Topical Solution USP, 1.5% include: dimethyl sulfoxide, alcohol (11.79%), propylene glycol, glycerin and purified water."
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{
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"Description": "Diclofenac Sodium Topical Solution USP, 1.5% is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application. Diclofenac Sodium Topical Solution USP, 1.5% contains 1.5% w/w diclofenac sodium, a benzene acetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzene acetic acid, monosodium salt. It is a white or slightly yellowish crystalline powder, slightly hygroscopic, and odorless that is freely soluble in methanol, soluble in alcohol, slightly soluble in acetone and sparingly soluble in water. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. The inactive ingredients in Diclofenac Sodium Topical Solution USP, 1.5% include: dimethyl sulfoxide, alcohol (11.79%), propylene glycol, glycerin and purified water."
},
{
"NDCCode": "52565-004-16",
"PackageDescription": "1 JAR in 1 CARTON (52565-004-16) > 453.6 g in 1 JAR",
"NDC11Code": "52565-0004-16",
"ProductNDC": "52565-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
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"DosageFormName": "CREAM",
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"ApplicationNumber": "ANDA203810",
"LabelerName": "Teligent Pharma, Inc.",
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},
{
"NDCCode": "52565-004-26",
"PackageDescription": "1 JAR in 1 CARTON (52565-004-26) > 453.6 g in 1 JAR",
"NDC11Code": "52565-0004-26",
"ProductNDC": "52565-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203810",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone Cream 2.5% contains hydrocortisone. Hydrocortisone is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is. Each gram of the 2.5% cream contains 25 mg of hydrocortisone in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, potassium sorbate, lactic acid, methylparaben, propylparaben, and purified water."
},
{
"NDCCode": "52565-004-30",
"PackageDescription": "1 TUBE in 1 CARTON (52565-004-30) > 30 g in 1 TUBE",
"NDC11Code": "52565-0004-30",
"ProductNDC": "52565-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203810",
"LabelerName": "Teligent Pharma, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
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"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone Cream 2.5% contains hydrocortisone. Hydrocortisone is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is. Each gram of the 2.5% cream contains 25 mg of hydrocortisone in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, potassium sorbate, lactic acid, methylparaben, propylparaben, and purified water."
}
]
}
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<ProductNDC>52565-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
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<NDC>
<NDCCode>52565-030-99</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52565-030-99) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>52565-0030-99</NDC11Code>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
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<NDC>
<NDCCode>52565-045-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52565-045-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>52565-0045-15</NDC11Code>
<ProductNDC>52565-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<SubstanceName>DESOXIMETASONE</SubstanceName>
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<StrengthUnit>mg/g</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>52565-045-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52565-045-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>52565-0045-30</NDC11Code>
<ProductNDC>52565-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20181023</StartMarketingDate>
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<SubstanceName>DESOXIMETASONE</SubstanceName>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<NDC>
<NDCCode>52565-045-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52565-045-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>52565-0045-60</NDC11Code>
<ProductNDC>52565-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
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<SubstanceName>DESOXIMETASONE</SubstanceName>
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<StrengthUnit>mg/g</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Ointment USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11ß,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
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<NDC>
<NDCCode>13107-045-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (13107-045-99) </PackageDescription>
<NDC11Code>13107-0045-99</NDC11Code>
<ProductNDC>13107-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201972</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone 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>Oxycodone hydrochloride and acetaminophen is available in tablets for oral administration. Each tablet, for oral administration, contains: Oxycodone Hydrochloride, USP……………...2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone) Acetaminophen, USP …………….............. 325 mg Oxycodone Hydrochloride, USP……………... 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone) Acetaminophen, USP ……………..................325 mg Oxycodone Hydrochloride, USP……………...10 mg* (* 10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone) Acetaminophen, USP ……………..................325 mg All strengths of Oxycodone Hydrochloride and Acetaminophen Tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white to off- white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>59779-045-99</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (59779-045-99) </PackageDescription>
<NDC11Code>59779-0045-99</NDC11Code>
<ProductNDC>59779-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Witch Hazel</ProprietaryName>
<NonProprietaryName>Witch Hazel</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>WITCH HAZEL</SubstanceName>
<StrengthNumber>860</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of minor skin irritations due to: 1 insect bites, 2 minor cuts, 3 minor scrapes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65862-045-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (65862-045-99) </PackageDescription>
<NDC11Code>65862-0045-99</NDC11Code>
<ProductNDC>65862-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077606</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>20; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using Lisinopril and Hydrochlorothiazide Tablets, USP consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS). In considering use of Lisinopril and Hydrochlorothiazide Tablets, USP it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema).</IndicationAndUsage>
<Description>Lisinopril and Hydrochlorothiazide Tablets combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O5 2H2O and its structural formula is. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is:. Hydrochlorothiazide USP is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP; Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg containing 20 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP; and, Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg containing 20 mg lisinopril USP and 25 mg hydrochlorothiazide USP. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize starch) and starch. Lisinopril and hydrochlorothiazide 10 mg/12.5 mg and 20 mg/25 mg also contains ferric oxide red and ferric oxide yellow. Lisinopril and hydrochlorothiazide 20 mg/12.5 mg also contains ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>83012-045-99</NDCCode>
<PackageDescription>20000 mL in 1 BAG (83012-045-99) </PackageDescription>
<NDC11Code>83012-0045-99</NDC11Code>
<ProductNDC>83012-045</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Adalimumab</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240113</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Boehringer Ingelheim Fremont, Inc.</LabelerName>
<SubstanceName>ADALIMUMAB-ADBM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-01</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49568-104-99</NDCCode>
<PackageDescription>65 kg in 1 DRUM (49568-104-99) </PackageDescription>
<NDC11Code>49568-0104-99</NDC11Code>
<ProductNDC>49568-104</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Livalo</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20100515</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Kowa Corporation Ltd.</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>1.045</StrengthNumber>
<StrengthUnit>mg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAY-10</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>53225-1070-1</NDCCode>
<PackageDescription>99 g in 1 TUBE (53225-1070-1) </PackageDescription>
<NDC11Code>53225-1070-01</NDC11Code>
<ProductNDC>53225-1070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona Gel</ProprietaryName>
<NonProprietaryName>Lidocaine 4.5%, Diclofenac 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220502</StartMarketingDate>
<EndMarketingDate>20250301</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Terrain Pharmaceuticals</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220502</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.</IndicationAndUsage>
<Description>Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Triethanolamine, Water.</Description>
</NDC>
<NDC>
<NDCCode>57337-045-01</NDCCode>
<PackageDescription>444 g in 1 BOTTLE (57337-045-01) </PackageDescription>
<NDC11Code>57337-0045-01</NDC11Code>
<ProductNDC>57337-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xtracare Foam Antibacterial Hand Wash</ProprietaryName>
<ProprietaryNameSuffix>Refill Vanilla Passion Flower</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Rejoice International</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/444g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XtraCare® Foam Antibacterial HAnd Wash. Kills 99.9% of bacteria. Refill. Compare to Lysol foam antibacterial hand wash. vanilla passion flower. 15 Fl Oz (444mL).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58503-045-01</NDCCode>
<PackageDescription>444 g in 1 BOTTLE (58503-045-01) </PackageDescription>
<NDC11Code>58503-0045-01</NDC11Code>
<ProductNDC>58503-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xtracare Foam Antibacterial Hand Wash</ProprietaryName>
<ProprietaryNameSuffix>Refill Vanilla Passion Flower</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>China Ningbo Shangge Cosmetic Technology Corp</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/444g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XtraCare® Foam Antibacterial HAnd Wash. Kills 99.9% of bacteria. Refill. Compare to Lysol foam antibacterial hand wash. vanilla passion flower. 15 Fl Oz (444mL).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68788-4013-9</NDCCode>
<PackageDescription>99 g in 1 TUBE (68788-4013-9) </PackageDescription>
<NDC11Code>68788-4013-09</NDC11Code>
<ProductNDC>68788-4013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona</ProprietaryName>
<NonProprietaryName>Lidocaine 4.5%, Diclofenac 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20250905</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.</IndicationAndUsage>
<Description>Diclona is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water.</Description>
</NDC>
<NDC>
<NDCCode>72189-688-35</NDCCode>
<PackageDescription>99 g in 1 TUBE (72189-688-35) </PackageDescription>
<NDC11Code>72189-0688-35</NDC11Code>
<ProductNDC>72189-688</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona Gel</ProprietaryName>
<NonProprietaryName>Diclona Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20260909</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.</IndicationAndUsage>
<Description>Diclona is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water.</Description>
</NDC>
<NDC>
<NDCCode>72197-045-06</NDCCode>
<PackageDescription>170 g in 1 JAR (72197-045-06) </PackageDescription>
<NDC11Code>72197-0045-06</NDC11Code>
<ProductNDC>72197-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pharmacys Prescription Petroleum Jelly</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210616</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>American Consumer Products Corp</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>99.9</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily protects minor: cuts, scrapes, burns Temporarily protects and helps relieve chapped or cracked skin and lips Helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-539-99</NDCCode>
<PackageDescription>99 g in 1 TUBE (76420-539-99) </PackageDescription>
<NDC11Code>76420-0539-99</NDC11Code>
<ProductNDC>76420-539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona Gel</ProprietaryName>
<NonProprietaryName>Lidocaine 4.5%, Diclofenac 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240103</StartMarketingDate>
<EndMarketingDate>20250301</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240103</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80425-0250-1</NDCCode>
<PackageDescription>99 g in 1 TUBE (80425-0250-1) </PackageDescription>
<NDC11Code>80425-0250-01</NDC11Code>
<ProductNDC>80425-0250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona Gel</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Diclofenac Sodium</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Rx Pharmacy of Tennessee, LLC</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.</IndicationAndUsage>
<Description>Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Triethanolamine, Water.</Description>
</NDC>
<NDC>
<NDCCode>80425-0517-1</NDCCode>
<PackageDescription>99 g in 1 TUBE (80425-0517-1) </PackageDescription>
<NDC11Code>80425-0517-01</NDC11Code>
<ProductNDC>80425-0517</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona</ProprietaryName>
<NonProprietaryName>Lidocaine 4.5%, Diclofenac 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20250505</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.</IndicationAndUsage>
<Description>Diclonais comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water.</Description>
</NDC>
<NDC>
<NDCCode>81968-045-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>81968-0045-14</NDC11Code>
<ProductNDC>81968-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240918</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>81968-045-30</NDCCode>
<PackageDescription>30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) </PackageDescription>
<NDC11Code>81968-0045-30</NDC11Code>
<ProductNDC>81968-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>81968-045-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>81968-0045-31</NDC11Code>
<ProductNDC>81968-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<EndMarketingDatePackage>20270328</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>81968-045-60</NDCCode>
<PackageDescription>60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) </PackageDescription>
<NDC11Code>81968-0045-60</NDC11Code>
<ProductNDC>81968-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvelity</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215430</ApplicationNumber>
<LabelerName>Axsome Therapeutics, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45; 105</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], 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>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NOHBrH2O and a molecular weight of 370.33 (271.4 dextromethorphan base). The structural formula is. Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. Bupropion hydrochloride has the empirical formula C13H18ClNOHCl and a molecular weight of 276.2 (239.74 bupropion base). The structural formula is. Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation. Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>83881-102-35</NDCCode>
<PackageDescription>99 g in 1 TUBE (83881-102-35) </PackageDescription>
<NDC11Code>83881-0102-35</NDC11Code>
<ProductNDC>83881-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclona</ProprietaryName>
<NonProprietaryName>Lidocaine 4.5%, Diclofenac 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20250415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Clinic Pharma</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .045</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclona is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.</IndicationAndUsage>
<Description>Diclona is comprised of a gel inside of a 3.5oz tube containing 4.5% Lidocaine and 1% Diclofenac Sodium. Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol, Water.</Description>
</NDC>
<NDC>
<NDCCode>84507-045-01</NDCCode>
<PackageDescription>30 g in 1 BOX (84507-045-01) </PackageDescription>
<NDC11Code>84507-0045-01</NDC11Code>
<ProductNDC>84507-045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rigboo 12% Gel Azelaic Acid Acne</ProprietaryName>
<NonProprietaryName>Acne Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250704</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Guangdong Miaolian Cosmetics Co., Ltd.</LabelerName>
<SubstanceName>CENTELLA ASIATICA LEAF; SALICYLIC ACID; AZELAIC ACID; QUATERNIUM-73</SubstanceName>
<StrengthNumber>.002; .99; .003; .07</StrengthNumber>
<StrengthUnit>mg/100g; mg/100g; mg/100g; mg/100g</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer one or three times daily.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52565-002-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52565-002-05) > 150 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>52565-0002-05</NDC11Code>
<ProductNDC>52565-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202769</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>16.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac Sodium Topical Solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).</IndicationAndUsage>
<Description>Diclofenac Sodium Topical Solution USP, 1.5% is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application. Diclofenac Sodium Topical Solution USP, 1.5% contains 1.5% w/w diclofenac sodium, a benzene acetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzene acetic acid, monosodium salt. It is a white or slightly yellowish crystalline powder, slightly hygroscopic, and odorless that is freely soluble in methanol, soluble in alcohol, slightly soluble in acetone and sparingly soluble in water. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. The inactive ingredients in Diclofenac Sodium Topical Solution USP, 1.5% include: dimethyl sulfoxide, alcohol (11.79%), propylene glycol, glycerin and purified water.</Description>
</NDC>
<NDC>
<NDCCode>52565-002-59</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52565-002-59) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>52565-0002-59</NDC11Code>
<ProductNDC>52565-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202769</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>16.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac Sodium Topical Solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).</IndicationAndUsage>
<Description>Diclofenac Sodium Topical Solution USP, 1.5% is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application. Diclofenac Sodium Topical Solution USP, 1.5% contains 1.5% w/w diclofenac sodium, a benzene acetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzene acetic acid, monosodium salt. It is a white or slightly yellowish crystalline powder, slightly hygroscopic, and odorless that is freely soluble in methanol, soluble in alcohol, slightly soluble in acetone and sparingly soluble in water. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. The inactive ingredients in Diclofenac Sodium Topical Solution USP, 1.5% include: dimethyl sulfoxide, alcohol (11.79%), propylene glycol, glycerin and purified water.</Description>
</NDC>
<NDC>
<NDCCode>52565-004-16</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (52565-004-16) > 453.6 g in 1 JAR</PackageDescription>
<NDC11Code>52565-0004-16</NDC11Code>
<ProductNDC>52565-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203810</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52565-004-26</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (52565-004-26) > 453.6 g in 1 JAR</PackageDescription>
<NDC11Code>52565-0004-26</NDC11Code>
<ProductNDC>52565-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203810</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone Cream 2.5% contains hydrocortisone. Hydrocortisone is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is. Each gram of the 2.5% cream contains 25 mg of hydrocortisone in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, potassium sorbate, lactic acid, methylparaben, propylparaben, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>52565-004-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52565-004-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>52565-0004-30</NDC11Code>
<ProductNDC>52565-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203810</ApplicationNumber>
<LabelerName>Teligent Pharma, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone Cream 2.5% contains hydrocortisone. Hydrocortisone is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is. Each gram of the 2.5% cream contains 25 mg of hydrocortisone in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, potassium sorbate, lactic acid, methylparaben, propylparaben, and purified water.</Description>
</NDC>
</NDCList>