{
"NDC": [
{
"NDCCode": "76420-473-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (76420-473-01) ",
"NDC11Code": "76420-0473-01",
"ProductNDC": "76420-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071456",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-335-16",
"PackageDescription": "473 mL in 1 BOTTLE (76420-335-16) ",
"NDC11Code": "76420-0335-16",
"ProductNDC": "76420-335",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240905",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA011265",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "6.25; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], 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": "2025-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.5 and 5.5. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid, black currant flavor, D&C Yellow 10, edetate disodium, FD&C Yellow 6, glycerin, L-Menthol, sodium benzoate, sodium citrate, sodium propionate, saccharin sodium, sucrose, and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10 H-Phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (+)- with the following structural formula:. Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula. Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C 18H 25NOHBrH 2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line)."
},
{
"NDCCode": "76420-473-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (76420-473-05) ",
"NDC11Code": "76420-0473-05",
"ProductNDC": "76420-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071456",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-473-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (76420-473-30) ",
"NDC11Code": "76420-0473-30",
"ProductNDC": "76420-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071456",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-473-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (76420-473-60) ",
"NDC11Code": "76420-0473-60",
"ProductNDC": "76420-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071456",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-473-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (76420-473-90) ",
"NDC11Code": "76420-0473-90",
"ProductNDC": "76420-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071456",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "0071-1020-01",
"PackageDescription": "473 mL in 1 BOTTLE (0071-1020-01) ",
"NDC11Code": "00071-1020-01",
"ProductNDC": "0071-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100104",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022488",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100104",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "0085-1334-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0085-1334-01) > 473 mL in 1 BOTTLE",
"NDC11Code": "00085-1334-01",
"ProductNDC": "0085-1334",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarinex",
"NonProprietaryName": "Desloratadine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021300",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "DESLORATADINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20040901",
"SamplePackage": "N"
},
{
"NDCCode": "0116-0101-01",
"PackageDescription": "473 mL in 1 BOTTLE (0116-0101-01) ",
"NDC11Code": "00116-0101-01",
"ProductNDC": "0116-0101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorhexidine Gluconate",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077789",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": ".12",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2020-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170630",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1 1-hexamethylene bis [5 - (p-chlorophenyl) biguanide] di-D-gluconate) in a base containing wate, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
},
{
"NDCCode": "0116-0244-01",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0116-0244-01) ",
"NDC11Code": "00116-0244-01",
"ProductNDC": "0116-0244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Denti-care Denti-rinse",
"ProprietaryNameSuffix": "Chlorhexidine Gluconate Oral Rinse",
"NonProprietaryName": "Chlorhexidine Gluconante",
"DosageFormName": "LIQUID",
"RouteName": "DENTAL",
"StartMarketingDate": "20060602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077789",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060602",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATION: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS.",
"Description": "DENTI-CARE. MEDICOM DENTI-RINSE 0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE MINT Item 10025-H Ingredients: 0.12 % chlorhexidine gluconate in a base containing water, 11.6 % alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD and C Blue No.1. Rx Only. KEEP OUT OF REACH OF CHILDREN 1 Pint (473 ml) NDC 64778-0244-1 M0701707V.2. DIRECTIONS FOR USE: Fill cap to the “fill line” (15 mL). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed. NOTE: To minimize medicinal taste, do not rinse with water immediately after use. To open: Squeeze smooth areas near bottom of cap and turn. To close: Turn Cap until it locks. WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE Your dentist has prescribed chlorhexidine gluconate oral rinse to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use chlorhexidine gluconate oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use; Chlorhexidine gluconate oral rinse should not be swallowed. Chlorhexidine gluconate oral rinse may cause some tooth discoloration, or increase in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every six months or more frequently if your dentist advises. Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor. Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components. Chlorhexidine gluconate oral rinse may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of chlorhexidine gluconate oral rinse. To avoid taste interference, rinse with chlorhexidine gluconate oral rinse after meals. Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse. If you have any questions or comments about chlorhexidine gluconate oral rinse, contact your dentist or pharmacist. Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)). Manufactured for and distributed by. AMD Medicom Inc. 2555 Chemin de l'Aviation. Pointe-Claire, Montreal, Quebec, Canada H9P 2Z2. DESCRIPTION: Chlorhexidine gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD and C Blue No.1. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid."
},
{
"NDCCode": "0116-0620-01",
"PackageDescription": "473 mL in 1 BOTTLE (0116-0620-01) ",
"NDC11Code": "00116-0620-01",
"ProductNDC": "0116-0620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peridex",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "19860813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019028",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19860813",
"SamplePackage": "N",
"IndicationAndUsage": "Peridex is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "Peridex (Chlorhexidine Gluconate 0.12%) Oral Rinse is an oral rinse containing 0.12% chlorhexidine gluconate (1, 1 1-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Peridex is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
},
{
"NDCCode": "0116-4075-01",
"PackageDescription": "473 mL in 1 BOTTLE (0116-4075-01) ",
"NDC11Code": "00116-4075-01",
"ProductNDC": "0116-4075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acclean Chlorhexidine Gluconate 0.12% Oral Rinse",
"NonProprietaryName": "Chlorhexidine Gluconate 0.12% Oral Rinse",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077789",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091001",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "ACCLEAN is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is."
},
{
"NDCCode": "0187-0003-01",
"PackageDescription": "473 mL in 1 BOTTLE (0187-0003-01)",
"NDC11Code": "00187-0003-01",
"ProductNDC": "0187-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capital And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20040503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086024",
"LabelerName": "Valeant Pharmaceuticals International",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "120; 12",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "0363-1591-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0363-1591-01) / 473 mL in 1 BOTTLE",
"NDC11Code": "00363-1591-01",
"ProductNDC": "0363-1591",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens Original T-gel",
"ProprietaryNameSuffix": "Anti-dandruff, Anti-seborrheic Dermatitis, Anti-psoriasis",
"NonProprietaryName": "Coal Tar",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240103",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Walgreen Company",
"SubstanceName": "COAL TAR",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240103",
"SamplePackage": "N",
"IndicationAndUsage": "controls the symptom of: 1 dandruff, 2 seborrheic dermatitis, 3 psoriasis."
},
{
"NDCCode": "0404-0012-01",
"PackageDescription": "473 mL in 1 BOTTLE (0404-0012-01) ",
"NDC11Code": "00404-0012-01",
"ProductNDC": "0404-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Henry Schein Mouth",
"NonProprietaryName": "1.5% Hydrogen Peroxide",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20210630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Henry Schein Inc.",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210630",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums."
},
{
"NDCCode": "0404-4075-01",
"PackageDescription": "473 mL in 1 BOTTLE (0404-4075-01) ",
"NDC11Code": "00404-4075-01",
"ProductNDC": "0404-4075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acclean Chlorhexidine Gluconate 0.12% Oral Rinse",
"NonProprietaryName": "Chlorhexidine Gluconate 0.12% Oral Rinse",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077789",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091001",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is."
},
{
"NDCCode": "0404-4438-01",
"PackageDescription": ".473 L in 1 BOTTLE (0404-4438-01) ",
"NDC11Code": "00404-4438-01",
"ProductNDC": "0404-4438",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "6.1",
"StrengthUnit": "g/L",
"Status": "Active",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130130",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Recommended for repeated use."
},
{
"NDCCode": "10237-268-01",
"PackageDescription": "1 KIT in 1 CARTON (10237-268-01) * 473 mL in 1 BOTTLE, PLASTIC * 473 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "10237-0268-01",
"ProductNDC": "10237-268",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therabreath",
"ProprietaryNameSuffix": "Am-pm Twin Pack",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20250203",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250203",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "10237-269-01",
"PackageDescription": "1 KIT in 1 CARTON (10237-269-01) * 473 mL in 1 BOTTLE, PLASTIC (10237-261-16) * 473 mL in 1 BOTTLE, PLASTIC (10237-258-16) ",
"NDC11Code": "10237-0269-01",
"ProductNDC": "10237-269",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therabreath",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N"
},
{
"NDCCode": "10237-274-01",
"PackageDescription": "1 KIT in 1 CARTON (10237-274-01) * 473 mL in 1 BOTTLE, PLASTIC (10237-260-16) * 473 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "10237-0274-01",
"ProductNDC": "10237-274",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therabreath",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "11754-473-01",
"PackageDescription": "473 mL in 1 BOTTLE (11754-473-01) ",
"NDC11Code": "11754-0473-01",
"ProductNDC": "11754-473",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL",
"StartMarketingDate": "20200520",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Puranic, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "354.75",
"StrengthUnit": "mL/473mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200520",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "12745-145-01",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (12745-145-01) ",
"NDC11Code": "12745-0145-01",
"ProductNDC": "12745-145",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bak",
"ProprietaryNameSuffix": "1 750",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19540615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Medical Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1713",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19540615",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions."
},
{
"NDCCode": "12745-850-01",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (12745-850-01) ",
"NDC11Code": "12745-0850-01",
"ProductNDC": "12745-850",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spectragenix Hand Sanitizer",
"ProprietaryNameSuffix": "Antiseptic Hand Wash",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Medical Chemical Corporation",
"SubstanceName": "ALCOHOL; DIAZOLIDINYL UREA",
"StrengthNumber": "55.34; .167",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201023",
"SamplePackage": "N",
"IndicationAndUsage": "Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes."
},
{
"NDCCode": "12745-851-01",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (12745-851-01) ",
"NDC11Code": "12745-0851-01",
"ProductNDC": "12745-851",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spectragenix Hand Sanitizer",
"ProprietaryNameSuffix": "Antiseptic Hand Wash",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Medical Chemical Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "55.34",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201023",
"SamplePackage": "N",
"IndicationAndUsage": "Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes."
},
{
"NDCCode": "13668-473-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13668-473-01) ",
"NDC11Code": "13668-0473-01",
"ProductNDC": "13668-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206937",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161021",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine tablets, USP are selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) (1.1).",
"Description": "Fluoxetine tablets, USP are a selective serotonin reuptake inhibitor (SSRI) for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each Fluoxetine tablets, USP contains fluoxetine hydrochloride equivalent to 10 mg or 20 mg of fluoxetine. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, D&C yellow no. 10 lake, FD&C yellow no. 6 lake, magnesium stearate, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "14141-473-01",
"PackageDescription": "1 TUBE in 1 BOX (14141-473-01) / 27 g in 1 TUBE",
"NDC11Code": "14141-0473-01",
"ProductNDC": "14141-473",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Forever Matte Base Control Brillo Y 90h Hidratacion Fps 15 Avellana 270c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260513",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BEL STAR S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "50; 29.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260513",
"SamplePackage": "N"
},
{
"NDCCode": "16477-185-01",
"PackageDescription": "473 mL in 1 BOTTLE (16477-185-01)",
"NDC11Code": "16477-0185-01",
"ProductNDC": "16477-185",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Donatussin",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20110928",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Laser Pharmaceuticals, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 120; 5",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "16477-186-01",
"PackageDescription": "473 mL in 1 BOTTLE (16477-186-01)",
"NDC11Code": "16477-0186-01",
"ProductNDC": "16477-186",
"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Laser Pharmaceuticals, LLC",
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"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
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"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Laser Pharmaceuticals, LLC",
"SubstanceName": "CHLORCYCLIZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
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<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<IndicationAndUsage>Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StrengthUnit>mg/1</StrengthUnit>
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<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<ProductNDC>76420-473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<PackageDescription>473 mL in 1 BOTTLE (0071-1020-01) </PackageDescription>
<NDC11Code>00071-1020-01</NDC11Code>
<ProductNDC>0071-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100104</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022488</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
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<StartMarketingDatePackage>20100104</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0085-1334-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0085-1334-01) > 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00085-1334-01</NDC11Code>
<ProductNDC>0085-1334</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarinex</ProprietaryName>
<NonProprietaryName>Desloratadine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021300</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>DESLORATADINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0116-0101-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0116-0101-01) </PackageDescription>
<NDC11Code>00116-0101-01</NDC11Code>
<ProductNDC>0116-0101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorhexidine Gluconate</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>.12</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1 1-hexamethylene bis [5 - (p-chlorophenyl) biguanide] di-D-gluconate) in a base containing wate, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
</NDC>
<NDC>
<NDCCode>0116-0244-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0116-0244-01) </PackageDescription>
<NDC11Code>00116-0244-01</NDC11Code>
<ProductNDC>0116-0244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Denti-care Denti-rinse</ProprietaryName>
<ProprietaryNameSuffix>Chlorhexidine Gluconate Oral Rinse</ProprietaryNameSuffix>
<NonProprietaryName>Chlorhexidine Gluconante</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20060602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATION: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS.</IndicationAndUsage>
<Description>DENTI-CARE. MEDICOM DENTI-RINSE 0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE MINT Item 10025-H Ingredients: 0.12 % chlorhexidine gluconate in a base containing water, 11.6 % alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD and C Blue No.1. Rx Only. KEEP OUT OF REACH OF CHILDREN 1 Pint (473 ml) NDC 64778-0244-1 M0701707V.2. DIRECTIONS FOR USE: Fill cap to the “fill line” (15 mL). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed. NOTE: To minimize medicinal taste, do not rinse with water immediately after use. To open: Squeeze smooth areas near bottom of cap and turn. To close: Turn Cap until it locks. WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE Your dentist has prescribed chlorhexidine gluconate oral rinse to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use chlorhexidine gluconate oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use; Chlorhexidine gluconate oral rinse should not be swallowed. Chlorhexidine gluconate oral rinse may cause some tooth discoloration, or increase in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every six months or more frequently if your dentist advises. Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor. Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components. Chlorhexidine gluconate oral rinse may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of chlorhexidine gluconate oral rinse. To avoid taste interference, rinse with chlorhexidine gluconate oral rinse after meals. Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse. If you have any questions or comments about chlorhexidine gluconate oral rinse, contact your dentist or pharmacist. Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)). Manufactured for and distributed by. AMD Medicom Inc. 2555 Chemin de l'Aviation. Pointe-Claire, Montreal, Quebec, Canada H9P 2Z2. DESCRIPTION: Chlorhexidine gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD and C Blue No.1. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.</Description>
</NDC>
<NDC>
<NDCCode>0116-0620-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0116-0620-01) </PackageDescription>
<NDC11Code>00116-0620-01</NDC11Code>
<ProductNDC>0116-0620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peridex</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019028</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Peridex is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>Peridex (Chlorhexidine Gluconate 0.12%) Oral Rinse is an oral rinse containing 0.12% chlorhexidine gluconate (1, 1 1-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Peridex is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
</NDC>
<NDC>
<NDCCode>0116-4075-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0116-4075-01) </PackageDescription>
<NDC11Code>00116-4075-01</NDC11Code>
<ProductNDC>0116-4075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acclean Chlorhexidine Gluconate 0.12% Oral Rinse</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate 0.12% Oral Rinse</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>ACCLEAN is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0187-0003-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0187-0003-01)</PackageDescription>
<NDC11Code>00187-0003-01</NDC11Code>
<ProductNDC>0187-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capital And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086024</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals International</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>120; 12</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0363-1591-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0363-1591-01) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-1591-01</NDC11Code>
<ProductNDC>0363-1591</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens Original T-gel</ProprietaryName>
<ProprietaryNameSuffix>Anti-dandruff, Anti-seborrheic Dermatitis, Anti-psoriasis</ProprietaryNameSuffix>
<NonProprietaryName>Coal Tar</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>COAL TAR</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>controls the symptom of: 1 dandruff, 2 seborrheic dermatitis, 3 psoriasis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0404-0012-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0404-0012-01) </PackageDescription>
<NDC11Code>00404-0012-01</NDC11Code>
<ProductNDC>0404-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Henry Schein Mouth</ProprietaryName>
<NonProprietaryName>1.5% Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Henry Schein Inc.</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0404-4075-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0404-4075-01) </PackageDescription>
<NDC11Code>00404-4075-01</NDC11Code>
<ProductNDC>0404-4075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acclean Chlorhexidine Gluconate 0.12% Oral Rinse</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate 0.12% Oral Rinse</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091001</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0404-4438-01</NDCCode>
<PackageDescription>.473 L in 1 BOTTLE (0404-4438-01) </PackageDescription>
<NDC11Code>00404-4438-01</NDC11Code>
<ProductNDC>0404-4438</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>6.1</StrengthNumber>
<StrengthUnit>g/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-268-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-268-01) * 473 mL in 1 BOTTLE, PLASTIC * 473 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>10237-0268-01</NDC11Code>
<ProductNDC>10237-268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therabreath</ProprietaryName>
<ProprietaryNameSuffix>Am-pm Twin Pack</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-269-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-269-01) * 473 mL in 1 BOTTLE, PLASTIC (10237-261-16) * 473 mL in 1 BOTTLE, PLASTIC (10237-258-16) </PackageDescription>
<NDC11Code>10237-0269-01</NDC11Code>
<ProductNDC>10237-269</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therabreath</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10237-274-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-274-01) * 473 mL in 1 BOTTLE, PLASTIC (10237-260-16) * 473 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>10237-0274-01</NDC11Code>
<ProductNDC>10237-274</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therabreath</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>11754-473-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (11754-473-01) </PackageDescription>
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<SubstanceName>ALCOHOL</SubstanceName>
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<StrengthUnit>mL/473mL</StrengthUnit>
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<LastUpdate>2022-01-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20200520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
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<NDC>
<NDCCode>12745-145-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (12745-145-01) </PackageDescription>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19540615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions.</IndicationAndUsage>
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<NDC>
<NDCCode>12745-850-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (12745-850-01) </PackageDescription>
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<ProductNDC>12745-850</ProductNDC>
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<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Medical Chemical Corporation</LabelerName>
<SubstanceName>ALCOHOL; DIAZOLIDINYL UREA</SubstanceName>
<StrengthNumber>55.34; .167</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12745-851-01</NDCCode>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spectragenix Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>Antiseptic Hand Wash</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Medical Chemical Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>55.34</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>13668-473-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13668-473-01) </PackageDescription>
<NDC11Code>13668-0473-01</NDC11Code>
<ProductNDC>13668-473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206937</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine tablets, USP are selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of Premenstrual Dysphoric Disorder (PMDD) (1.1).</IndicationAndUsage>
<Description>Fluoxetine tablets, USP are a selective serotonin reuptake inhibitor (SSRI) for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each Fluoxetine tablets, USP contains fluoxetine hydrochloride equivalent to 10 mg or 20 mg of fluoxetine. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, D&C yellow no. 10 lake, FD&C yellow no. 6 lake, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
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<NDC>
<NDCCode>14141-473-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14141-473-01) / 27 g in 1 TUBE</PackageDescription>
<NDC11Code>14141-0473-01</NDC11Code>
<ProductNDC>14141-473</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Forever Matte Base Control Brillo Y 90h Hidratacion Fps 15 Avellana 270c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260513</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BEL STAR S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>50; 29.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>16477-185-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (16477-185-01)</PackageDescription>
<NDC11Code>16477-0185-01</NDC11Code>
<ProductNDC>16477-185</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Donatussin</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110928</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Laser Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 120; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
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<NDC>
<NDCCode>16477-186-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (16477-186-01)</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Donatussin</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20140219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Laser Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4; 20; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>16477-562-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (16477-562-01)</PackageDescription>
<NDC11Code>16477-0562-01</NDC11Code>
<ProductNDC>16477-562</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neo</ProprietaryName>
<ProprietaryNameSuffix>Dm</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, And Brompheniramine Maleate</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Laser Pharmaceuticals LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>30; 50; 3</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16477-820-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (16477-820-01)</PackageDescription>
<NDC11Code>16477-0820-01</NDC11Code>
<ProductNDC>16477-820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dallergy</ProprietaryName>
<NonProprietaryName>Chlorcyclizine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Laser Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CHLORCYCLIZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
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