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"ProprietaryName": "Flawless Tinted Moisturizer Medium",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Droxidopa",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214543",
"LabelerName": "Tris Pharma Inc",
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"StrengthNumber": "100",
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"Pharm_Classes": "Catecholamines [CS],Increased Blood Pressure [PE]",
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"ProductNDC": "49281-860",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Ipol",
"NonProprietaryName": "Poliovirus Type 1 Antigen (formaldehyde Inactivated), Poliovirus Type 2 Antigen (formaldehyde Inactivated), And Poliovirus Type 3 Antigen (formaldehyde Inactivated)",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103930",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "40; 8; 32",
"StrengthUnit": "[D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
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"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19901221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103930",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
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"StrengthUnit": "[D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
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"LastUpdate": "2026-09-23",
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"StartMarketingDatePackage": "19901221",
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"IndicationAndUsage": "IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3. (28).",
"Description": "IPOL®, Poliovirus Vaccine Inactivated, produced by Sanofi Winthrop Industrie , is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL vaccine is a highly purified, inactivated poliovirus vaccine with enhanced potency. Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers. (1) (2) The cells are grown in Eagle MEM modified medium, supplemented with newborn calf bovine serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth, the culture medium is replaced by M-199, without calf bovine serum. This culture technique and improvements in purification, concentration, and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the inactivated poliovirus vaccine (IPV) available in the US prior to 1988. (3) (4). After clarification and filtration, viral suspensions are concentrated by ultrafiltration, and purified by three liquid chromatography steps; one column of anion exchanger, one column of gel filtration, and again one column of anion exchanger. After re-equilibration of the purified viral suspension with Medium M-199 and adjustment of the antigen titer, the monovalent viral suspensions are inactivated at +37°C for at least 12 days with 1:4000 formalin. Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay. IPOL vaccine is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin, and polymyxin B are used in vaccine production; and, although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin, and 25 ng polymyxin B per dose may still be present. The residual calf bovine serum albumin is less than 50 ng/dose in the final vaccine. The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously. The vial stopper is not made with natural rubber latex."
},
{
"NDCCode": "54473-199-01",
"PackageDescription": "1 BOTTLE in 1 BOX (54473-199-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "54473-0199-01",
"ProductNDC": "54473-199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sei Bella",
"ProprietaryNameSuffix": "Age Defying Foundation Porcelain",
"NonProprietaryName": "Homosalate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110502",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Melaleuca, Inc.",
"SubstanceName": "HOMOSALATE",
"StrengthNumber": "2.9313",
"StrengthUnit": "g/30mL",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
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"NDCCode": "73333-199-01",
"PackageDescription": "96 g in 1 TUBE (73333-199-01) ",
"NDC11Code": "73333-0199-01",
"ProductNDC": "73333-199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maesa - Hey Humans",
"NonProprietaryName": "Wintermint Mint Chill",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Nutrix International, LLC.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "g/96g",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210214",
"SamplePackage": "N",
"IndicationAndUsage": "Helps protect against cavities."
},
{
"NDCCode": "75834-199-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (75834-199-01) ",
"NDC11Code": "75834-0199-01",
"ProductNDC": "75834-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ofloxacin",
"NonProprietaryName": "Ofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091656",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "OFLOXACIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190125",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets, USP and other antibacterial drugs, ofloxacin tablets, USP 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. Ofloxacin tablets, USP are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Warnings), -and for some patients ABECB is self-limiting, reserve ofloxacin for treatment of ABECB in patients who have no alternative treatment options. Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae. Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis. Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae (see WARNINGS). Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis (see WARNINGS). Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae (see WARNINGS). Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae (see WARNINGS). NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered. Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see WARNINGS), and for some patients uncomplicated cystitis is self-limiting, reserve ofloxacin for treatment of uncomplicated cystitis in patients who have no alternative treatment options. Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus,= Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. or Pseudomonas aeruginosa. Prostatitis due to Escherichia coli. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to ofloxacin, USP. Therapy with ofloxacin, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin, USP. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.",
"Description": "Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, USP, a fluorinated carboxyquinolone, is the racemate, (±)-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. The chemical structure is. C18H20FN3O4 M.W. 361.4. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that ofloxacin, USP is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni +2 > Pb+2 > Zn+2 > Mg+2 > Ca +2 > Ba +2. Ofloxacin Tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized maize starch, hydroxy propyl methyl cellulose, talc, magnesium stearate, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg and 400 mg tablets contain iron oxide yellow. The imprinting ink for 200 mg, 300 mg and 400 mg strength contains FD&C blue #1, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "75834-199-05",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (75834-199-05) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20190125",
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"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "OFLOXACIN",
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"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190125",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets, USP and other antibacterial drugs, ofloxacin tablets, USP 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. Ofloxacin tablets, USP are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Warnings), -and for some patients ABECB is self-limiting, reserve ofloxacin for treatment of ABECB in patients who have no alternative treatment options. Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae. Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis. Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae (see WARNINGS). Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis (see WARNINGS). Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae (see WARNINGS). Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae (see WARNINGS). NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered. Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see WARNINGS), and for some patients uncomplicated cystitis is self-limiting, reserve ofloxacin for treatment of uncomplicated cystitis in patients who have no alternative treatment options. Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus,= Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. or Pseudomonas aeruginosa. Prostatitis due to Escherichia coli. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to ofloxacin, USP. Therapy with ofloxacin, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin, USP. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.",
"Description": "Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, USP, a fluorinated carboxyquinolone, is the racemate, (±)-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. The chemical structure is. C18H20FN3O4 M.W. 361.4. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that ofloxacin, USP is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni +2 > Pb+2 > Zn+2 > Mg+2 > Ca +2 > Ba +2. Ofloxacin Tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized maize starch, hydroxy propyl methyl cellulose, talc, magnesium stearate, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg and 400 mg tablets contain iron oxide yellow. The imprinting ink for 200 mg, 300 mg and 400 mg strength contains FD&C blue #1, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and titanium dioxide."
},
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"StartMarketingDatePackage": "20190125",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets, USP and other antibacterial drugs, ofloxacin tablets, USP 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. Ofloxacin tablets, USP are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Warnings), -and for some patients ABECB is self-limiting, reserve ofloxacin for treatment of ABECB in patients who have no alternative treatment options. Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae. Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis. Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae (see WARNINGS). Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis (see WARNINGS). Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae (see WARNINGS). Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae (see WARNINGS). NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered. Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see WARNINGS), and for some patients uncomplicated cystitis is self-limiting, reserve ofloxacin for treatment of uncomplicated cystitis in patients who have no alternative treatment options. Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus,= Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. or Pseudomonas aeruginosa. Prostatitis due to Escherichia coli. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to ofloxacin, USP. Therapy with ofloxacin, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin, USP. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.",
"Description": "Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, USP, a fluorinated carboxyquinolone, is the racemate, (±)-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. The chemical structure is. C18H20FN3O4 M.W. 361.4. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that ofloxacin, USP is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni +2 > Pb+2 > Zn+2 > Mg+2 > Ca +2 > Ba +2. Ofloxacin Tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized maize starch, hydroxy propyl methyl cellulose, talc, magnesium stearate, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg and 400 mg tablets contain iron oxide yellow. The imprinting ink for 200 mg, 300 mg and 400 mg strength contains FD&C blue #1, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "82649-199-30",
"PackageDescription": "300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (82649-199-30) ",
"NDC11Code": "82649-0199-30",
"ProductNDC": "82649-199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20220826",
"EndMarketingDate": "20250826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "LifeMD",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220826",
"EndMarketingDatePackage": "20250826",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "87063-199-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-01) ",
"NDC11Code": "87063-0199-01",
"ProductNDC": "87063-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079229",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, and magnesium stearate. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. 0.5 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and polysorbate 80. 1 mg: hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and polysorbate 80. 3 mg: hypromellose, titanium dioxide, carmine, polyethylene glycol, polysorbate 80 and FD&C Blue No. 1. 4 mg: hypromellose, titanium dioxide, iron oxide red, polyethylene glycol, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg: hypromellose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 and polysorbate 80."
},
{
"NDCCode": "87063-199-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-30) ",
"NDC11Code": "87063-0199-30",
"ProductNDC": "87063-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079229",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, and magnesium stearate. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. 0.5 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and polysorbate 80. 1 mg: hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and polysorbate 80. 3 mg: hypromellose, titanium dioxide, carmine, polyethylene glycol, polysorbate 80 and FD&C Blue No. 1. 4 mg: hypromellose, titanium dioxide, iron oxide red, polyethylene glycol, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg: hypromellose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 and polysorbate 80."
},
{
"NDCCode": "87063-199-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-60) ",
"NDC11Code": "87063-0199-60",
"ProductNDC": "87063-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079229",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, and magnesium stearate. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. 0.5 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and polysorbate 80. 1 mg: hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and polysorbate 80. 3 mg: hypromellose, titanium dioxide, carmine, polyethylene glycol, polysorbate 80 and FD&C Blue No. 1. 4 mg: hypromellose, titanium dioxide, iron oxide red, polyethylene glycol, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg: hypromellose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 and polysorbate 80."
},
{
"NDCCode": "87063-199-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-90) ",
"NDC11Code": "87063-0199-90",
"ProductNDC": "87063-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079229",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"Description": "Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, and magnesium stearate. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. 0.5 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and polysorbate 80. 1 mg: hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and polysorbate 80. 3 mg: hypromellose, titanium dioxide, carmine, polyethylene glycol, polysorbate 80 and FD&C Blue No. 1. 4 mg: hypromellose, titanium dioxide, iron oxide red, polyethylene glycol, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg: hypromellose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 and polysorbate 80."
},
{
"NDCCode": "76947-198-20",
"PackageDescription": "5000 mL in 1 BOTTLE (76947-198-20) ",
"NDC11Code": "76947-0198-20",
"ProductNDC": "76947-198",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SNS Distribution LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/70mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: for hand washing to decrease bacteria on skin. Keep out of reach of children. Do not use near eyes, in case of contact rinse eyes thorouhly with water."
},
{
"NDCCode": "76947-198-21",
"PackageDescription": "5000 mL in 1 BOTTLE (76947-198-21) ",
"NDC11Code": "76947-0198-21",
"ProductNDC": "76947-198",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SNS Distribution LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/70mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: for hand washing to decrease bacteria on skin. Keep out of reach of children. Do not use near eyes, in case of contact rinse eyes thorouhly with water."
},
{
"NDCCode": "10096-0201-2",
"PackageDescription": "1 CASE in 1 CARTON (10096-0201-2) > 4.2 g in 1 CASE (10096-0201-1)",
"NDC11Code": "10096-0201-02",
"ProductNDC": "10096-0201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mark",
"ProprietaryNameSuffix": "Totally Balmed",
"NonProprietaryName": "Octinoxate, Oxybenzone, Octisalate, Avobenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100602",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Avon Products, Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE",
"StrengthNumber": "294; 199.5; 199.5; 84",
"StrengthUnit": "mg/4.2g; mg/4.2g; mg/4.2g; mg/4.2g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10544-199-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (10544-199-90)",
"NDC11Code": "10544-0199-90",
"ProductNDC": "10544-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077901",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents."
},
{
"NDCCode": "10596-199-05",
"PackageDescription": "1 TUBE in 1 BOX (10596-199-05) / 14 g in 1 TUBE",
"NDC11Code": "10596-0199-05",
"ProductNDC": "10596-199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biore",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250211",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250211",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the treatment of acne."
},
{
"NDCCode": "10695-199-50",
"PackageDescription": "5 kg in 1 CONTAINER (10695-199-50) ",
"NDC11Code": "10695-0199-50",
"ProductNDC": "10695-199",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Metformin Hcl",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220718",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Willow Birch Pharma, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-02-22",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "18-JUL-22"
},
{
"NDCCode": "10812-199-01",
"PackageDescription": "10 g in 1 TUBE (10812-199-01)",
"NDC11Code": "10812-0199-01",
"ProductNDC": "10812-199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Moistureshine Lip Soother",
"ProprietaryNameSuffix": "Sunscreen Spf20 - Shimmer 10",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130611",
"EndMarketingDate": "20171201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 20",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "10893-199-10",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (10893-199-10) > 1 LIQUID in 1 BOTTLE, GLASS",
"NDC11Code": "10893-0199-10",
"ProductNDC": "10893-199",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil",
"ProprietaryNameSuffix": "Cherry Angiomas",
"NonProprietaryName": "Phosphoricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation",
"SubstanceName": "PHOSPHORIC ACID",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11054-001-04",
"PackageDescription": "199 L in 1 CYLINDER (11054-001-04) ",
"NDC11Code": "11054-0001-04",
"ProductNDC": "11054-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206023",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "210",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "19971106",
"SamplePackage": "N"
},
{
"NDCCode": "11054-009-17",
"PackageDescription": "199 L in 1 CYLINDER (11054-009-17) ",
"NDC11Code": "11054-0009-17",
"ProductNDC": "11054-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "CUTANEOUS; RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971014",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205840",
"LabelerName": "Airgas USA, LLC",
"SubstanceName": "OXYGEN",
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<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
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<LastUpdate>2024-11-01</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flawless Tinted Moisturizer Medium</ProprietaryName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Anastasia Beverly Hills</LabelerName>
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<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>27808-199-19</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (27808-199-19) </PackageDescription>
<NDC11Code>27808-0199-19</NDC11Code>
<ProductNDC>27808-199</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Droxidopa</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Tris Pharma Inc</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catecholamines [CS],Increased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductNDC>49281-860</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Ipol</ProprietaryName>
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<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19901221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103930</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>40; 8; 32</StrengthNumber>
<StrengthUnit>[D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
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<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3. (28).</IndicationAndUsage>
<Description>IPOL®, Poliovirus Vaccine Inactivated, produced by Sanofi Winthrop Industrie , is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL vaccine is a highly purified, inactivated poliovirus vaccine with enhanced potency. Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers. (1) (2) The cells are grown in Eagle MEM modified medium, supplemented with newborn calf bovine serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth, the culture medium is replaced by M-199, without calf bovine serum. This culture technique and improvements in purification, concentration, and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the inactivated poliovirus vaccine (IPV) available in the US prior to 1988. (3) (4). After clarification and filtration, viral suspensions are concentrated by ultrafiltration, and purified by three liquid chromatography steps; one column of anion exchanger, one column of gel filtration, and again one column of anion exchanger. After re-equilibration of the purified viral suspension with Medium M-199 and adjustment of the antigen titer, the monovalent viral suspensions are inactivated at +37°C for at least 12 days with 1:4000 formalin. Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay. IPOL vaccine is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin, and polymyxin B are used in vaccine production; and, although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin, and 25 ng polymyxin B per dose may still be present. The residual calf bovine serum albumin is less than 50 ng/dose in the final vaccine. The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously. The vial stopper is not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>50090-1693-9</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 PACKAGE (50090-1693-9) / 5 mL in 1 VIAL, MULTI-DOSE (50090-1693-0) </PackageDescription>
<NDC11Code>50090-1693-09</NDC11Code>
<ProductNDC>50090-1693</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Ipol</ProprietaryName>
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<StartMarketingDate>19901221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103930</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
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<StrengthUnit>[D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19901221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3. (28).</IndicationAndUsage>
<Description>IPOL®, Poliovirus Vaccine Inactivated, produced by Sanofi Winthrop Industrie , is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL vaccine is a highly purified, inactivated poliovirus vaccine with enhanced potency. Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers. (1) (2) The cells are grown in Eagle MEM modified medium, supplemented with newborn calf bovine serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth, the culture medium is replaced by M-199, without calf bovine serum. This culture technique and improvements in purification, concentration, and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the inactivated poliovirus vaccine (IPV) available in the US prior to 1988. (3) (4). After clarification and filtration, viral suspensions are concentrated by ultrafiltration, and purified by three liquid chromatography steps; one column of anion exchanger, one column of gel filtration, and again one column of anion exchanger. After re-equilibration of the purified viral suspension with Medium M-199 and adjustment of the antigen titer, the monovalent viral suspensions are inactivated at +37°C for at least 12 days with 1:4000 formalin. Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay. IPOL vaccine is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin, and polymyxin B are used in vaccine production; and, although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin, and 25 ng polymyxin B per dose may still be present. The residual calf bovine serum albumin is less than 50 ng/dose in the final vaccine. The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously. The vial stopper is not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>54473-199-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54473-199-01) > 30 mL in 1 BOTTLE</PackageDescription>
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<ProductNDC>54473-199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sei Bella</ProprietaryName>
<ProprietaryNameSuffix>Age Defying Foundation Porcelain</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110502</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Melaleuca, Inc.</LabelerName>
<SubstanceName>HOMOSALATE</SubstanceName>
<StrengthNumber>2.9313</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>73333-199-01</NDCCode>
<PackageDescription>96 g in 1 TUBE (73333-199-01) </PackageDescription>
<NDC11Code>73333-0199-01</NDC11Code>
<ProductNDC>73333-199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maesa - Hey Humans</ProprietaryName>
<NonProprietaryName>Wintermint Mint Chill</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20210214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Nutrix International, LLC.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>g/96g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75834-199-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (75834-199-01) </PackageDescription>
<NDC11Code>75834-0199-01</NDC11Code>
<ProductNDC>75834-199</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ofloxacin</ProprietaryName>
<NonProprietaryName>Ofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091656</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OFLOXACIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190125</StartMarketingDatePackage>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets, USP and other antibacterial drugs, ofloxacin tablets, USP 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. Ofloxacin tablets, USP are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see Warnings), -and for some patients ABECB is self-limiting, reserve ofloxacin for treatment of ABECB in patients who have no alternative treatment options. Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae. Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis. Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae (see WARNINGS). Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis (see WARNINGS). Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae (see WARNINGS). Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae (see WARNINGS). NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered. Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa. Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions (see WARNINGS), and for some patients uncomplicated cystitis is self-limiting, reserve ofloxacin for treatment of uncomplicated cystitis in patients who have no alternative treatment options. Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus,= Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. or Pseudomonas aeruginosa. Prostatitis due to Escherichia coli. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to ofloxacin, USP. Therapy with ofloxacin, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin, USP. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, USP, a fluorinated carboxyquinolone, is the racemate, (±)-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. The chemical structure is. C18H20FN3O4 M.W. 361.4. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that ofloxacin, USP is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni +2 > Pb+2 > Zn+2 > Mg+2 > Ca +2 > Ba +2. Ofloxacin Tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized maize starch, hydroxy propyl methyl cellulose, talc, magnesium stearate, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg and 400 mg tablets contain iron oxide yellow. The imprinting ink for 200 mg, 300 mg and 400 mg strength contains FD&C blue #1, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and titanium dioxide.</Description>
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<Description>Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, USP, a fluorinated carboxyquinolone, is the racemate, (±)-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. The chemical structure is. C18H20FN3O4 M.W. 361.4. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that ofloxacin, USP is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni +2 > Pb+2 > Zn+2 > Mg+2 > Ca +2 > Ba +2. Ofloxacin Tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized maize starch, hydroxy propyl methyl cellulose, talc, magnesium stearate, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg and 400 mg tablets contain iron oxide yellow. The imprinting ink for 200 mg, 300 mg and 400 mg strength contains FD&C blue #1, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and titanium dioxide.</Description>
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<Description>Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, USP, a fluorinated carboxyquinolone, is the racemate, (±)-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. The chemical structure is. C18H20FN3O4 M.W. 361.4. Ofloxacin, USP is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin, USP at room temperature, as defined by USP nomenclature, indicate that ofloxacin, USP is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni +2 > Pb+2 > Zn+2 > Mg+2 > Ca +2 > Ba +2. Ofloxacin Tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized maize starch, hydroxy propyl methyl cellulose, talc, magnesium stearate, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg and 400 mg tablets contain iron oxide yellow. The imprinting ink for 200 mg, 300 mg and 400 mg strength contains FD&C blue #1, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and titanium dioxide.</Description>
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<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, and magnesium stearate. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. 0.5 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and polysorbate 80. 1 mg: hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and polysorbate 80. 3 mg: hypromellose, titanium dioxide, carmine, polyethylene glycol, polysorbate 80 and FD&C Blue No. 1. 4 mg: hypromellose, titanium dioxide, iron oxide red, polyethylene glycol, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg: hypromellose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 and polysorbate 80.</Description>
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<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, and magnesium stearate. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. 0.5 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and polysorbate 80. 1 mg: hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and polysorbate 80. 3 mg: hypromellose, titanium dioxide, carmine, polyethylene glycol, polysorbate 80 and FD&C Blue No. 1. 4 mg: hypromellose, titanium dioxide, iron oxide red, polyethylene glycol, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg: hypromellose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 and polysorbate 80.</Description>
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<SamplePackage>N</SamplePackage>
<Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, and magnesium stearate. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. 0.5 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and polysorbate 80. 1 mg: hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and polysorbate 80. 3 mg: hypromellose, titanium dioxide, carmine, polyethylene glycol, polysorbate 80 and FD&C Blue No. 1. 4 mg: hypromellose, titanium dioxide, iron oxide red, polyethylene glycol, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg: hypromellose, titanium dioxide, polyethylene glycol, FD&C Blue No. 2 and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>76947-198-20</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE (76947-198-20) </PackageDescription>
<NDC11Code>76947-0198-20</NDC11Code>
<ProductNDC>76947-198</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SNS Distribution LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/70mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: for hand washing to decrease bacteria on skin. Keep out of reach of children. Do not use near eyes, in case of contact rinse eyes thorouhly with water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76947-198-21</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE (76947-198-21) </PackageDescription>
<NDC11Code>76947-0198-21</NDC11Code>
<ProductNDC>76947-198</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SNS Distribution LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/70mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: for hand washing to decrease bacteria on skin. Keep out of reach of children. Do not use near eyes, in case of contact rinse eyes thorouhly with water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10096-0201-2</NDCCode>
<PackageDescription>1 CASE in 1 CARTON (10096-0201-2) > 4.2 g in 1 CASE (10096-0201-1)</PackageDescription>
<NDC11Code>10096-0201-02</NDC11Code>
<ProductNDC>10096-0201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mark</ProprietaryName>
<ProprietaryNameSuffix>Totally Balmed</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Oxybenzone, Octisalate, Avobenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Avon Products, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE</SubstanceName>
<StrengthNumber>294; 199.5; 199.5; 84</StrengthNumber>
<StrengthUnit>mg/4.2g; mg/4.2g; mg/4.2g; mg/4.2g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10544-199-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (10544-199-90)</PackageDescription>
<NDC11Code>10544-0199-90</NDC11Code>
<ProductNDC>10544-199</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077901</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10596-199-05</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10596-199-05) / 14 g in 1 TUBE</PackageDescription>
<NDC11Code>10596-0199-05</NDC11Code>
<ProductNDC>10596-199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biore</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Kao USA Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10695-199-50</NDCCode>
<PackageDescription>5 kg in 1 CONTAINER (10695-199-50) </PackageDescription>
<NDC11Code>10695-0199-50</NDC11Code>
<ProductNDC>10695-199</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Metformin Hcl</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220718</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Willow Birch Pharma, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-02-22</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-JUL-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>10812-199-01</NDCCode>
<PackageDescription>10 g in 1 TUBE (10812-199-01)</PackageDescription>
<NDC11Code>10812-0199-01</NDC11Code>
<ProductNDC>10812-199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Moistureshine Lip Soother</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Spf20 - Shimmer 10</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130611</StartMarketingDate>
<EndMarketingDate>20171201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>10893-199-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (10893-199-10) > 1 LIQUID in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>10893-0199-10</NDC11Code>
<ProductNDC>10893-199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil</ProprietaryName>
<ProprietaryNameSuffix>Cherry Angiomas</ProprietaryNameSuffix>
<NonProprietaryName>Phosphoricum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation</LabelerName>
<SubstanceName>PHOSPHORIC ACID</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11054-001-04</NDCCode>
<PackageDescription>199 L in 1 CYLINDER (11054-001-04) </PackageDescription>
<NDC11Code>11054-0001-04</NDC11Code>
<ProductNDC>11054-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206023</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11054-009-17</NDCCode>
<PackageDescription>199 L in 1 CYLINDER (11054-009-17) </PackageDescription>
<NDC11Code>11054-0009-17</NDC11Code>
<ProductNDC>11054-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>CUTANEOUS; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971014</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205840</ApplicationNumber>
<LabelerName>Airgas USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11054-110-04</NDCCode>
<PackageDescription>199 L in 1 CYLINDER (11054-110-04) </PackageDescription>
<NDC11Code>11054-0110-04</NDC11Code>
<ProductNDC>11054-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205845</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11344-199-14</NDCCode>
<PackageDescription>162.7 mL in 1 CAN (11344-199-14) </PackageDescription>
<NDC11Code>11344-0199-14</NDC11Code>
<ProductNDC>11344-199</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11344-234-63</NDCCode>
<PackageDescription>199 mL in 1 BOTTLE, PLASTIC (11344-234-63) </PackageDescription>
<NDC11Code>11344-0234-63</NDC11Code>
<ProductNDC>11344-234</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germ-x</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990712</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi Jon, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>63</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decreast bacteria on the skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11344-849-63</NDCCode>
<PackageDescription>199 mL in 1 BOTTLE, PLASTIC (11344-849-63) </PackageDescription>
<NDC11Code>11344-0849-63</NDC11Code>
<ProductNDC>11344-849</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>