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"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide."
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"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide."
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"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide."
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"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide."
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "0096-0736-08",
"PackageDescription": "249.6 g in 1 BOTTLE (0096-0736-08) ",
"NDC11Code": "00096-0736-08",
"ProductNDC": "0096-0736",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dhs Tar Gel",
"NonProprietaryName": "Coal Tar",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Person and Covey",
"SubstanceName": "COAL TAR",
"StrengthNumber": ".005",
"StrengthUnit": "g/g",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent recurrence of scalp itching and flaking associated with Psoriasis, Seborrheic Dermatitis and Dandruff."
},
{
"NDCCode": "0113-0096-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (0113-0096-91) ",
"NDC11Code": "00113-0096-91",
"ProductNDC": "0113-0096",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Flu And Severe Cold And Cough",
"ProprietaryNameSuffix": "Daytime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110131",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "0338-0096-06",
"PackageDescription": "6 BAG in 1 CARTON (0338-0096-06) / 150 mL in 1 BAG",
"NDC11Code": "00338-0096-06",
"ProductNDC": "0338-0096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207131",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "3",
"StrengthUnit": "g/150mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for: : 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: (1) οRespiratory tract infections (1.1);οUrinary tract infections (1.2);οSkin and skin structure infections (1.3);οBiliary tract infections (1.4);οBone and joint infections (1.5);οGenital infections (1.6);οSepticemia (1.7);οEndocarditis (1.8), 2 Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this formulation can be achieved (1.9) .",
"Description": "Cefazolin in Dextrose Injection is a frozen, premixed, iso-osmotic, sterile, nonpyrogenic, single-dose solution containing either 1 g Cefazolin, USP, equivalent to 1.05 g Cefazolin Sodium, USP per 50 mL, 2 g Cefazolin, USP, equivalent to 2.1 g Cefazolin Sodium, USP per 100 mL or 3 g Cefazolin, USP, equivalent to 3.15 g Cefazolin Sodium, USP per 150 mL Galaxy container (PL 2040 Plastic). Dextrose, USP has been added to adjust osmolality (4 % as dextrose hydrous). The approximate osmolality for Cefazolin in Dextrose Injection is 290 mOsmol/kg. Cefazolin Sodium is a semi-synthetic cephalosporin antibacterial for parenteral administration and has the following IUPAC nomenclature: Sodium (6R,7R)-3-[[(5-methyl-1,3,4- thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2- ene-2-carboxylate. Its molecular formula is C14H13N8O4S3·Na and its molecular weight is 454.51 (free acid). Cefazolin Sodium USP has the following structural formula. The sodium content is 48 mg/g of cefazolin sodium. The pH of Cefazolin in Dextrose Injection may have been adjusted with sodium bicarbonate, or sodium hydroxide/hydrochloric acid during manufacture. Water for injection, USP is added as drug vehicle. Contains no preservative. The solution is intended for intravenous use after thawing to room temperature. This Galaxy container (PL 2040 Plastic) is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0363-0096-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (0363-0096-91)",
"NDC11Code": "00363-0096-91",
"ProductNDC": "0363-0096",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal Flu Severe Cold And Cough",
"ProprietaryNameSuffix": "Daytime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120117",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-03-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0363-1119-55",
"PackageDescription": "1 KIT in 1 CARTON (0363-1119-55) * 6 POWDER, FOR SOLUTION in 1 CARTON (0363-0096-91) * 6 POWDER, FOR SOLUTION in 1 CARTON (0363-0964-91) ",
"NDC11Code": "00363-1119-55",
"ProductNDC": "0363-1119",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal Flu Severe Cold And Cough",
"ProprietaryNameSuffix": "Daytime Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20151204",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"Status": "Deprecated",
"LastUpdate": "2020-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20151204",
"SamplePackage": "N"
},
{
"NDCCode": "0555-0096-96",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0555-0096-96) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "00555-0096-96",
"ProductNDC": "0555-0096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20050811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077194",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20050811",
"SamplePackage": "N"
},
{
"NDCCode": "10210-0096-1",
"PackageDescription": "1 KIT in 1 KIT (10210-0096-1) * 10 g in 1 TUBE (10210-0022-6) * 2 CYLINDER in 1 TRAY (10210-0053-1) / 4.25 g in 1 CYLINDER",
"NDC11Code": "10210-0096-01",
"ProductNDC": "10210-0096",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carmex Classic Lip Balm Medicated",
"NonProprietaryName": "Camphor (synthetic), White Petrolatum",
"DosageFormName": "KIT",
"StartMarketingDate": "20160926",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Carma Laboratories, Inc.",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160926",
"SamplePackage": "N"
},
{
"NDCCode": "11014-0096-1",
"PackageDescription": "6 POUCH in 1 CARTON (11014-0096-1) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL",
"NDC11Code": "11014-0096-01",
"ProductNDC": "11014-0096",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Budesonide",
"DosageFormName": "SUSPENSION",
"StartMarketingDate": "20141124",
"EndMarketingDate": "20180322",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/2mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20180322"
},
{
"NDCCode": "11523-0096-6",
"PackageDescription": "4 TUBE in 1 CARTON (11523-0096-6) / 113 g in 1 TUBE",
"NDC11Code": "11523-0096-06",
"ProductNDC": "11523-0096",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "A And D Original",
"NonProprietaryName": "Lanolin And Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030604",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "LANOLIN; PETROLATUM",
"StrengthNumber": "136.4; 469.9",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "helps treat and prevent diaper rash. temporarily protects minor: cuts scrapes burns . temporarily protects and helps relieve chapped, chafed or cracked skin and lips. protect chafed skin due to diaper rash and helps seal out wetness."
},
{
"NDCCode": "11822-0096-1",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (11822-0096-1) ",
"NDC11Code": "11822-0096-01",
"ProductNDC": "11822-0096",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Severe Cold Cough And Flu Relief",
"ProprietaryNameSuffix": "Daytime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150805",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150805",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "85534-0096-6",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (85534-0096-6) ",
"NDC11Code": "85534-0096-06",
"ProductNDC": "85534-0096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201043",
"LabelerName": "HAWAII REPACK, INC.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260718",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1, 12.4). : 1 Pneumonia: Nosocomial ( 1.1) and Community Acquired ( 1.2,1.3) , 2 Skin and Skin Structure Infections (SSSI): Complicated ( 1.4) and Uncomplicated ( 1.5) , 3 Chronic bacterial prostatitis ( 1.6) , 4 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7) , 5 Plague in adult and pediatric patients ( 1.8) , 6 Urinary Tract Infections (UTI): Complicated ( 1.9, 1.10) and Uncomplicated ( 1.12) , 7 Acute Pyelonephritis ( 1.11) , 8 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13) , 9 Acute Bacterial Sinusitis ( 1.14) .",
"Description": "Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C 18H 20FN 3O 4 ½ H 2O and the molecular weight is 370.38. Levofloxacin USP is a pale or bright yellow, crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely solublein this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely solublein this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitrochelation potential has the following formation order: Al +3>Cu +2>Zn +2>Mg +2>Ca +2. Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg, 500 mg and 750 mg (as expressed in the anhydrous form): croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. In addition 250 mg contains iron oxide red and 500 mg contains iron oxide red and iron oxide yellow. Meets USP dissolution test 4."
},
{
"NDCCode": "0096-0682-04",
"PackageDescription": "129 g in 1 BOTTLE (0096-0682-04) ",
"NDC11Code": "00096-0682-04",
"ProductNDC": "0096-0682",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solbar Shield Spf40",
"NonProprietaryName": "Solbar Shield Spf40",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Person and Covey",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".05; .075",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Dosage and Administration: Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician."
},
{
"NDCCode": "0096-0687-04",
"PackageDescription": "119 g in 1 BOTTLE (0096-0687-04) ",
"NDC11Code": "00096-0687-04",
"ProductNDC": "0096-0687",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solbar Avo Spf35",
"NonProprietaryName": "Solbar Avo Spf35",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Person and Covey",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE",
"StrengthNumber": ".08; .075; .06; .03",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Dosage and Administration: Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician."
},
{
"NDCCode": "10544-096-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-096-21)",
"NDC11Code": "10544-0096-21",
"ProductNDC": "10544-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062058",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red. No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin."
},
{
"NDCCode": "10544-096-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-096-30)",
"NDC11Code": "10544-0096-30",
"ProductNDC": "10544-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130116",
"MarketingCategoryName": "ANDA",
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"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red. No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin."
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<ApplicationNumber>ANDA078722</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
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<NDCCode>71335-0096-5</NDCCode>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20190927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-0096-8</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (71335-0096-8) </PackageDescription>
<NDC11Code>71335-0096-08</NDC11Code>
<ProductNDC>71335-0096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078722</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-0096-9</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (71335-0096-9) </PackageDescription>
<NDC11Code>71335-0096-09</NDC11Code>
<ProductNDC>71335-0096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078722</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP for oral administration, is available in 7.5 mg strength. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0096-0685-04</NDCCode>
<PackageDescription>105.6 g in 1 BOTTLE (0096-0685-04) </PackageDescription>
<NDC11Code>00096-0685-04</NDC11Code>
<ProductNDC>0096-0685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solbar Thirty Spf 30</ProprietaryName>
<NonProprietaryName>Solbar Thirty Spf30</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Person and Covey</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>.12; .075; .06; .03; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0096-0736-08</NDCCode>
<PackageDescription>249.6 g in 1 BOTTLE (0096-0736-08) </PackageDescription>
<NDC11Code>00096-0736-08</NDC11Code>
<ProductNDC>0096-0736</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dhs Tar Gel</ProprietaryName>
<NonProprietaryName>Coal Tar</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Person and Covey</LabelerName>
<SubstanceName>COAL TAR</SubstanceName>
<StrengthNumber>.005</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent recurrence of scalp itching and flaking associated with Psoriasis, Seborrheic Dermatitis and Dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0113-0096-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (0113-0096-91) </PackageDescription>
<NDC11Code>00113-0096-91</NDC11Code>
<ProductNDC>0113-0096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Flu And Severe Cold And Cough</ProprietaryName>
<ProprietaryNameSuffix>Daytime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0338-0096-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0338-0096-06) / 150 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-0096-06</NDC11Code>
<ProductNDC>0338-0096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207131</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/150mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for: : 1 Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: (1) οRespiratory tract infections (1.1);οUrinary tract infections (1.2);οSkin and skin structure infections (1.3);οBiliary tract infections (1.4);οBone and joint infections (1.5);οGenital infections (1.6);οSepticemia (1.7);οEndocarditis (1.8), 2 Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this formulation can be achieved (1.9) .</IndicationAndUsage>
<Description>Cefazolin in Dextrose Injection is a frozen, premixed, iso-osmotic, sterile, nonpyrogenic, single-dose solution containing either 1 g Cefazolin, USP, equivalent to 1.05 g Cefazolin Sodium, USP per 50 mL, 2 g Cefazolin, USP, equivalent to 2.1 g Cefazolin Sodium, USP per 100 mL or 3 g Cefazolin, USP, equivalent to 3.15 g Cefazolin Sodium, USP per 150 mL Galaxy container (PL 2040 Plastic). Dextrose, USP has been added to adjust osmolality (4 % as dextrose hydrous). The approximate osmolality for Cefazolin in Dextrose Injection is 290 mOsmol/kg. Cefazolin Sodium is a semi-synthetic cephalosporin antibacterial for parenteral administration and has the following IUPAC nomenclature: Sodium (6R,7R)-3-[[(5-methyl-1,3,4- thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2- ene-2-carboxylate. Its molecular formula is C14H13N8O4S3·Na and its molecular weight is 454.51 (free acid). Cefazolin Sodium USP has the following structural formula. The sodium content is 48 mg/g of cefazolin sodium. The pH of Cefazolin in Dextrose Injection may have been adjusted with sodium bicarbonate, or sodium hydroxide/hydrochloric acid during manufacture. Water for injection, USP is added as drug vehicle. Contains no preservative. The solution is intended for intravenous use after thawing to room temperature. This Galaxy container (PL 2040 Plastic) is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0363-0096-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (0363-0096-91)</PackageDescription>
<NDC11Code>00363-0096-91</NDC11Code>
<ProductNDC>0363-0096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal Flu Severe Cold And Cough</ProprietaryName>
<ProprietaryNameSuffix>Daytime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-03-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0363-1119-55</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0363-1119-55) * 6 POWDER, FOR SOLUTION in 1 CARTON (0363-0096-91) * 6 POWDER, FOR SOLUTION in 1 CARTON (0363-0964-91) </PackageDescription>
<NDC11Code>00363-1119-55</NDC11Code>
<ProductNDC>0363-1119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal Flu Severe Cold And Cough</ProprietaryName>
<ProprietaryNameSuffix>Daytime Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0555-0096-96</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0555-0096-96) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-0096-96</NDC11Code>
<ProductNDC>0555-0096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077194</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10210-0096-1</NDCCode>
<PackageDescription>1 KIT in 1 KIT (10210-0096-1) * 10 g in 1 TUBE (10210-0022-6) * 2 CYLINDER in 1 TRAY (10210-0053-1) / 4.25 g in 1 CYLINDER</PackageDescription>
<NDC11Code>10210-0096-01</NDC11Code>
<ProductNDC>10210-0096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carmex Classic Lip Balm Medicated</ProprietaryName>
<NonProprietaryName>Camphor (synthetic), White Petrolatum</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160926</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Carma Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11014-0096-1</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (11014-0096-1) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>11014-0096-01</NDC11Code>
<ProductNDC>11014-0096</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<StartMarketingDate>20141124</StartMarketingDate>
<EndMarketingDate>20180322</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20180322</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11523-0096-6</NDCCode>
<PackageDescription>4 TUBE in 1 CARTON (11523-0096-6) / 113 g in 1 TUBE</PackageDescription>
<NDC11Code>11523-0096-06</NDC11Code>
<ProductNDC>11523-0096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A And D Original</ProprietaryName>
<NonProprietaryName>Lanolin And Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030604</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>LANOLIN; PETROLATUM</SubstanceName>
<StrengthNumber>136.4; 469.9</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps treat and prevent diaper rash. temporarily protects minor: cuts scrapes burns . temporarily protects and helps relieve chapped, chafed or cracked skin and lips. protect chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0096-1</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (11822-0096-1) </PackageDescription>
<NDC11Code>11822-0096-01</NDC11Code>
<ProductNDC>11822-0096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Severe Cold Cough And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Daytime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150805</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. cough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85534-0096-6</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (85534-0096-6) </PackageDescription>
<NDC11Code>85534-0096-06</NDC11Code>
<ProductNDC>85534-0096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201043</ApplicationNumber>
<LabelerName>HAWAII REPACK, INC.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1, 12.4). : 1 Pneumonia: Nosocomial ( 1.1) and Community Acquired ( 1.2,1.3) , 2 Skin and Skin Structure Infections (SSSI): Complicated ( 1.4) and Uncomplicated ( 1.5) , 3 Chronic bacterial prostatitis ( 1.6) , 4 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7) , 5 Plague in adult and pediatric patients ( 1.8) , 6 Urinary Tract Infections (UTI): Complicated ( 1.9, 1.10) and Uncomplicated ( 1.12) , 7 Acute Pyelonephritis ( 1.11) , 8 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13) , 9 Acute Bacterial Sinusitis ( 1.14) .</IndicationAndUsage>
<Description>Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C 18H 20FN 3O 4 ½ H 2O and the molecular weight is 370.38. Levofloxacin USP is a pale or bright yellow, crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely solublein this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely solublein this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitrochelation potential has the following formation order: Al +3>Cu +2>Zn +2>Mg +2>Ca +2. Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg, 500 mg and 750 mg (as expressed in the anhydrous form): croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. In addition 250 mg contains iron oxide red and 500 mg contains iron oxide red and iron oxide yellow. Meets USP dissolution test 4.</Description>
</NDC>
<NDC>
<NDCCode>0096-0682-04</NDCCode>
<PackageDescription>129 g in 1 BOTTLE (0096-0682-04) </PackageDescription>
<NDC11Code>00096-0682-04</NDC11Code>
<ProductNDC>0096-0682</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solbar Shield Spf40</ProprietaryName>
<NonProprietaryName>Solbar Shield Spf40</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Person and Covey</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.05; .075</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Dosage and Administration: Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0096-0687-04</NDCCode>
<PackageDescription>119 g in 1 BOTTLE (0096-0687-04) </PackageDescription>
<NDC11Code>00096-0687-04</NDC11Code>
<ProductNDC>0096-0687</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solbar Avo Spf35</ProprietaryName>
<NonProprietaryName>Solbar Avo Spf35</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Person and Covey</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE</SubstanceName>
<StrengthNumber>.08; .075; .06; .03</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Dosage and Administration: Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10544-096-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-096-21)</PackageDescription>
<NDC11Code>10544-0096-21</NDC11Code>
<ProductNDC>10544-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062058</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red. No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>10544-096-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (10544-096-30)</PackageDescription>
<NDC11Code>10544-0096-30</NDC11Code>
<ProductNDC>10544-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062058</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red. No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>10544-096-42</NDCCode>
<PackageDescription>42 CAPSULE in 1 BOTTLE (10544-096-42)</PackageDescription>
<NDC11Code>10544-0096-42</NDC11Code>
<ProductNDC>10544-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062058</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red. No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>11489-096-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-096-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0096-01</NDC11Code>
<ProductNDC>11489-096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Botanics Shine Away Mattifying Day Cream Sunscreen Broad Spectrum Spf 15</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.5; 1.5; 2.5</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions for sunscreen use. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-096-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (11673-096-91)</PackageDescription>
<NDC11Code>11673-0096-91</NDC11Code>
<ProductNDC>11673-096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Flu And Severe Cold And Cough Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13630-0096-4</NDCCode>
<PackageDescription>177 mL in 1 CAN (13630-0096-4) </PackageDescription>
<NDC11Code>13630-0096-04</NDC11Code>
<ProductNDC>13630-0096</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prebel</ProprietaryName>
<ProprietaryNameSuffix>Nude Protect Spf 70 Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Oxybenzone And Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120307</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>25.6; 106.5; 42.6; 23.43; 51.12</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>