RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (13 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "10237-700-72",
      "PackageDescription": "2 CAN in 1 PACKAGE (10237-700-72)  / 211 mL in 1 CAN",
      "NDC11Code": "10237-0700-72",
      "ProductNDC": "10237-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Simply Saline",
      "ProprietaryNameSuffix": "Wound Care",
      "NonProprietaryName": "Benzethonium Chloride 0.13%",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "BENZETHONIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/13mL",
      "Status": "Active",
      "LastUpdate": "2025-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250601",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "10237-700-71",
      "PackageDescription": "211 mL in 1 CAN (10237-700-71) ",
      "NDC11Code": "10237-0700-71",
      "ProductNDC": "10237-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Simply Saline",
      "ProprietaryNameSuffix": "Wound Care",
      "NonProprietaryName": "Benzethonium Chloride 0.13%",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "BENZETHONIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/13mL",
      "Status": "Active",
      "LastUpdate": "2025-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180518",
      "SamplePackage": "N",
      "IndicationAndUsage": "First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "42507-208-72",
      "PackageDescription": "1 KIT in 1 CARTON (42507-208-72)  *  8 BLISTER PACK in 1 CARTON (42507-998-62)  > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK *  16 BLISTER PACK in 1 CARTON (42507-700-62)  > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "42507-0208-72",
      "ProductNDC": "42507-208",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cold And Flu",
      "ProprietaryNameSuffix": "Day Night",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20141014",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "HyVee Inc",
      "Status": "Deprecated",
      "LastUpdate": "2018-09-02",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "59779-700-72",
      "PackageDescription": "1 BOTTLE in 1 CARTON (59779-700-72)  > 60 TABLET, FILM COATED in 1 BOTTLE",
      "NDC11Code": "59779-0700-72",
      "ProductNDC": "59779-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti Diarrheal",
      "NonProprietaryName": "Loperamide Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030224",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075232",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20120221",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71205-700-72",
      "PackageDescription": "120 TABLET in 1 BOTTLE (71205-700-72) ",
      "NDC11Code": "71205-0700-72",
      "ProductNDC": "71205-700",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride (allergy)",
      "NonProprietaryName": "Cetirizine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150805",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090760",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240308",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "10237-626-72",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-626-72)  > 204 g in 1 TUBE",
      "NDC11Code": "10237-0626-72",
      "ProductNDC": "10237-626",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aim Cavity Protection",
      "ProprietaryNameSuffix": "Multi Benefit",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20040301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10237-633-72",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-633-72)  > 204 g in 1 TUBE",
      "NDC11Code": "10237-0633-72",
      "ProductNDC": "10237-633",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aim Cavity Protection",
      "ProprietaryNameSuffix": "Multi Benefit",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20040301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-28",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "10237-644-72",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-644-72)  > 204 g in 1 TUBE",
      "NDC11Code": "10237-0644-72",
      "ProductNDC": "10237-644",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Close Up",
      "ProprietaryNameSuffix": "Freshening With Mouthwash",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20010301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20010301",
      "EndMarketingDatePackage": "20220525",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10237-653-72",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-653-72)  > 204 g in 1 TUBE",
      "NDC11Code": "10237-0653-72",
      "ProductNDC": "10237-653",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Complete Care Tartar Control",
      "ProprietaryNameSuffix": "Plus Whitening Baking Soda And Peroxide",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20120129",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10237-655-72",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-655-72)  > 204 g in 1 TUBE",
      "NDC11Code": "10237-0655-72",
      "ProductNDC": "10237-655",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Peroxie Care Tartar Control",
      "ProprietaryNameSuffix": "Healthy Gums Baking Soda And Peroxide",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20120129",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10237-656-72",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-656-72)  > 204 g in 1 TUBE",
      "NDC11Code": "10237-0656-72",
      "ProductNDC": "10237-656",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Advance White",
      "ProprietaryNameSuffix": "Tartar Control Breath Freshening",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20120129",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10237-658-72",
      "PackageDescription": "1 TUBE in 1 CARTON (10237-658-72)  / 204 g in 1 TUBE",
      "NDC11Code": "10237-0658-72",
      "ProductNDC": "10237-658",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Advance White Extreme Whitening",
      "ProprietaryNameSuffix": "Tartar Control",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20120129",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120129",
      "EndMarketingDatePackage": "20241231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use  aids in the prevention of dental decay."
    },
    {
      "NDCCode": "13811-700-30",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30) ",
      "NDC11Code": "13811-0700-30",
      "ProductNDC": "13811-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220623",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA216117",
      "LabelerName": "Trigen Laboratories, LLC",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "63",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-09-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220623",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
      "Description": "Methylphenidate hydrochloride extended-release tablets contain methylphenidate a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets are for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). Methylphenidate hydrochloride extended-release tablets contain the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. Methylphenidate hydrochloride extended-release tablets also contain the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized."
    },
    {
      "NDCCode": "44567-700-25",
      "PackageDescription": "25 VIAL in 1 CARTON (44567-700-25)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "44567-0700-25",
      "ProductNDC": "44567-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ceftriaxone",
      "NonProprietaryName": "Ceftriaxone",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20080724",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065329",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "CEFTRIAXONE SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080724",
      "SamplePackage": "N",
      "IndicationAndUsage": "Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for Injection, 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. Ceftriaxone for Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms. LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of Ceftriaxone for Injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose Ceftriaxone for Injection, USP and the comparator. The potentially lower clinical cure rate of Ceftriaxone for Injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii,* Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for Injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for Injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.*. *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of Ceftriaxone for Injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Ceftriaxone for Injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of Ceftriaxone for Injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure.",
      "Description": "Ceftriaxone for Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S3·3.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula. Ceftriaxone for Injection, USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity."
    },
    {
      "NDCCode": "65219-656-10",
      "PackageDescription": "24 POUCH in 1 CARTON (65219-656-10)  / 1 BAG in 1 POUCH (65219-656-01)  / 100 mL in 1 BAG",
      "NDC11Code": "65219-0656-10",
      "ProductNDC": "65219-656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphates",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250615",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212832",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
      "StrengthNumber": "11.2; 11.8",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.",
      "Description": "Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container."
    },
    {
      "NDCCode": "65219-658-25",
      "PackageDescription": "30 POUCH in 1 CARTON (65219-658-25)  / 1 BAG in 1 POUCH (65219-658-01)  / 250 mL in 1 BAG",
      "NDC11Code": "65219-0658-25",
      "ProductNDC": "65219-658",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Phosphates",
      "NonProprietaryName": "Potassium Phosphates",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20250615",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212832",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
      "StrengthNumber": "4.48; 4.72",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.",
      "Description": "Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container."
    },
    {
      "NDCCode": "65862-700-20",
      "PackageDescription": "20 TABLET in 1 BOTTLE (65862-700-20) ",
      "NDC11Code": "65862-0700-20",
      "ProductNDC": "65862-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefuroxime Axetil",
      "NonProprietaryName": "Cefuroxime Axetil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060329",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065308",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CEFUROXIME AXETIL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060329",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).",
      "Description": "Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: Tablets are film-coated and contain the equivalent of 125 mg, 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide."
    },
    {
      "NDCCode": "65862-700-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (65862-700-60) ",
      "NDC11Code": "65862-0700-60",
      "ProductNDC": "65862-700",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefuroxime Axetil",
      "NonProprietaryName": "Cefuroxime Axetil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060329",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065308",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CEFUROXIME AXETIL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20060329",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).",
      "Description": "Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: Tablets are film-coated and contain the equivalent of 125 mg, 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide."
    },
    {
      "NDCCode": "10237-001-00",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (10237-001-00)  / 100 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "10237-0001-00",
      "ProductNDC": "10237-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hero Pore Release Blackhead Clearing",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230701",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the treatment of acne. reduces the number of blackheads. helps keep skin clear of new blackheads."
    },
    {
      "NDCCode": "10237-002-50",
      "PackageDescription": "150 mL in 1 TUBE (10237-002-50) ",
      "NDC11Code": "10237-0002-50",
      "ProductNDC": "10237-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hero Mighty Cleanser",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20260701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260701",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes from forming."
    },
    {
      "NDCCode": "10237-003-00",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (10237-003-00)  / 10 mL in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "10237-0003-00",
      "ProductNDC": "10237-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240115",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the treatment of acne. Clears acne blemishes and allows skin to heal. Helps prevent new acne blemishes from forming."
    },
    {
      "NDCCode": "10237-004-00",
      "PackageDescription": "1 TUBE, WITH APPLICATOR in 1 BOX (10237-004-00)  / 50 mL in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "10237-0004-00",
      "ProductNDC": "10237-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hero Force Shield Superbeam Sunscreen Spf 30 Apricot",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "175.3",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
    },
    {
      "NDCCode": "10237-005-50",
      "PackageDescription": "150 mL in 1 TUBE (10237-005-50) ",
      "NDC11Code": "10237-0005-50",
      "ProductNDC": "10237-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hero Pore Cleanser",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20260701",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260701",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes from forming."
    },
    {
      "NDCCode": "10237-100-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-100-01)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0100-01",
      "ProductNDC": "10237-100",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Touchland Power Mist Hand Sanitizer Wild Watermelon",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Church & Dwight Co., Inc",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
    },
    {
      "NDCCode": "10237-101-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-101-01)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0101-01",
      "ProductNDC": "10237-101",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Touchland Power Mist Hand Sanitizer Aloe You",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
    },
    {
      "NDCCode": "10237-102-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-102-01)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0102-01",
      "ProductNDC": "10237-102",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Touchland Power Mist Hand Sanitizer Berry Bliss",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
    },
    {
      "NDCCode": "10237-103-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-103-01)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0103-01",
      "ProductNDC": "10237-103",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Touchland Power Mist Hand Sanitizer Blue Sandalwood",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
    },
    {
      "NDCCode": "10237-104-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-104-01)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0104-01",
      "ProductNDC": "10237-104",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Touchland Power Mist Hand Sanitizer Citrus Grove",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "thand sanitizer o decrease bacteria on the skin recommended for repeated use."
    },
    {
      "NDCCode": "10237-105-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-105-01)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0105-01",
      "ProductNDC": "10237-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Touchland Power Mist Hand Sanitizer Frosted Mint",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".7",
      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin recommended for repeated use."
    },
    {
      "NDCCode": "10237-106-01",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-106-01)  / 30 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "10237-0106-01",
      "ProductNDC": "10237-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Touchland Power Mist Hand Sanitizer Lemon Lime Spritz",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Church & Dwight Co., Inc.",
      "SubstanceName": "ALCOHOL",
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      "StrengthUnit": "mL/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220101",
      "SamplePackage": "N",
      "IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
    }
  ]
}
                    

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<NDCList>
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    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
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    <StrengthUnit>mg/13mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDCCode>10237-700-71</NDCCode>
    <PackageDescription>211 mL in 1 CAN (10237-700-71) </PackageDescription>
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    <LabelerName>HyVee Inc</LabelerName>
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    <LastUpdate>2018-09-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>71205-700-72</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (71205-700-72) </PackageDescription>
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    <ProductNDC>71205-700</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090760</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240308</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
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  <NDC>
    <NDCCode>10237-626-72</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-626-72)  &gt; 204 g in 1 TUBE</PackageDescription>
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    <ProductNDC>10237-626</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aim Cavity Protection</ProprietaryName>
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    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
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    <RouteName>DENTAL</RouteName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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    <PackageDescription>1 TUBE in 1 CARTON (10237-633-72)  &gt; 204 g in 1 TUBE</PackageDescription>
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    <ProprietaryName>Aim Cavity Protection</ProprietaryName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-28</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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    <PackageDescription>1 TUBE in 1 CARTON (10237-644-72)  &gt; 204 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0644-72</NDC11Code>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20010301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220525</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>10237-653-72</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-653-72)  &gt; 204 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0653-72</NDC11Code>
    <ProductNDC>10237-653</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Complete Care Tartar Control</ProprietaryName>
    <ProprietaryNameSuffix>Plus Whitening Baking Soda And Peroxide</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20120129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>10237-655-72</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-655-72)  &gt; 204 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0655-72</NDC11Code>
    <ProductNDC>10237-655</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Peroxie Care Tartar Control</ProprietaryName>
    <ProprietaryNameSuffix>Healthy Gums Baking Soda And Peroxide</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20120129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>10237-656-72</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-656-72)  &gt; 204 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0656-72</NDC11Code>
    <ProductNDC>10237-656</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advance White</ProprietaryName>
    <ProprietaryNameSuffix>Tartar Control Breath Freshening</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
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    <StartMarketingDate>20120129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>10237-658-72</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-658-72)  / 204 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0658-72</NDC11Code>
    <ProductNDC>10237-658</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Advance White Extreme Whitening</ProprietaryName>
    <ProprietaryNameSuffix>Tartar Control</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20120129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120129</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use  aids in the prevention of dental decay.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13811-700-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30) </PackageDescription>
    <NDC11Code>13811-0700-30</NDC11Code>
    <ProductNDC>13811-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220623</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA216117</ApplicationNumber>
    <LabelerName>Trigen Laboratories, LLC</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>63</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-09-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release tablets contain methylphenidate a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets are for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). Methylphenidate hydrochloride extended-release tablets contain the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. Methylphenidate hydrochloride extended-release tablets also contain the following color additives:. 27 mg: FD&amp;C Yellow #6 Aluminum Lake, FD&amp;C Blue #2 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake. 45 mg: FD&amp;C Red #40 Aluminum Lake. 54 mg: FD&amp;C Yellow #6 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake, FD&amp;C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&amp;C Blue #1 Aluminum Lake. System Components and Performance. Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.</Description>
  </NDC>
  <NDC>
    <NDCCode>44567-700-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (44567-700-25)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>44567-0700-25</NDC11Code>
    <ProductNDC>44567-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ceftriaxone</ProprietaryName>
    <NonProprietaryName>Ceftriaxone</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20080724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065329</ApplicationNumber>
    <LabelerName>WG Critical Care, LLC</LabelerName>
    <SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for Injection, 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. Ceftriaxone for Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms. LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of Ceftriaxone for Injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose Ceftriaxone for Injection, USP and the comparator. The potentially lower clinical cure rate of Ceftriaxone for Injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii,* Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for Injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for Injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli.*. *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of Ceftriaxone for Injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Ceftriaxone for Injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of Ceftriaxone for Injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure.</IndicationAndUsage>
    <Description>Ceftriaxone for Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S3·3.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula. Ceftriaxone for Injection, USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-656-10</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (65219-656-10)  / 1 BAG in 1 POUCH (65219-656-01)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>65219-0656-10</NDC11Code>
    <ProductNDC>65219-656</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Phosphates</ProprietaryName>
    <NonProprietaryName>Potassium Phosphates</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250615</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212832</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>11.2; 11.8</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.</IndicationAndUsage>
    <Description>Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container.</Description>
  </NDC>
  <NDC>
    <NDCCode>65219-658-25</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (65219-658-25)  / 1 BAG in 1 POUCH (65219-658-01)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>65219-0658-25</NDC11Code>
    <ProductNDC>65219-658</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Phosphates</ProprietaryName>
    <NonProprietaryName>Potassium Phosphates</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250615</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212832</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>4.48; 4.72</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.</IndicationAndUsage>
    <Description>Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. For 100 mL single-dose container:. Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container. Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more than 100 mcg/L of aluminum. The osmolality is 500-700 mOsmol/kg for the 100 mL single-dose container and 300-500 mOsmol/kg for the 250 mL single-dose container.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-700-20</NDCCode>
    <PackageDescription>20 TABLET in 1 BOTTLE (65862-700-20) </PackageDescription>
    <NDC11Code>65862-0700-20</NDC11Code>
    <ProductNDC>65862-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefuroxime Axetil</ProprietaryName>
    <NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065308</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>CEFUROXIME AXETIL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).</IndicationAndUsage>
    <Description>Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: Tablets are film-coated and contain the equivalent of 125 mg, 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-700-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (65862-700-60) </PackageDescription>
    <NDC11Code>65862-0700-60</NDC11Code>
    <ProductNDC>65862-700</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefuroxime Axetil</ProprietaryName>
    <NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20060329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065308</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>CEFUROXIME AXETIL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).</IndicationAndUsage>
    <Description>Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula: Tablets are film-coated and contain the equivalent of 125 mg, 250 mg or 500 mg of cefuroxime as cefuroxime axetil USP. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10237-001-00</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (10237-001-00)  / 100 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>10237-0001-00</NDC11Code>
    <ProductNDC>10237-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hero Pore Release Blackhead Clearing</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the treatment of acne. reduces the number of blackheads. helps keep skin clear of new blackheads.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-002-50</NDCCode>
    <PackageDescription>150 mL in 1 TUBE (10237-002-50) </PackageDescription>
    <NDC11Code>10237-0002-50</NDC11Code>
    <ProductNDC>10237-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hero Mighty Cleanser</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes from forming.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-003-00</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (10237-003-00)  / 10 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>10237-0003-00</NDC11Code>
    <ProductNDC>10237-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of acne. Clears acne blemishes and allows skin to heal. Helps prevent new acne blemishes from forming.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-004-00</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 BOX (10237-004-00)  / 50 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>10237-0004-00</NDC11Code>
    <ProductNDC>10237-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hero Force Shield Superbeam Sunscreen Spf 30 Apricot</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>175.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-005-50</NDCCode>
    <PackageDescription>150 mL in 1 TUBE (10237-005-50) </PackageDescription>
    <NDC11Code>10237-0005-50</NDC11Code>
    <ProductNDC>10237-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hero Pore Cleanser</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes from forming.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-100-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-100-01)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0100-01</NDC11Code>
    <ProductNDC>10237-100</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Touchland Power Mist Hand Sanitizer Wild Watermelon</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-101-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-101-01)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0101-01</NDC11Code>
    <ProductNDC>10237-101</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Touchland Power Mist Hand Sanitizer Aloe You</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-102-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-102-01)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0102-01</NDC11Code>
    <ProductNDC>10237-102</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Touchland Power Mist Hand Sanitizer Berry Bliss</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-103-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-103-01)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0103-01</NDC11Code>
    <ProductNDC>10237-103</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Touchland Power Mist Hand Sanitizer Blue Sandalwood</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-104-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-104-01)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0104-01</NDC11Code>
    <ProductNDC>10237-104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Touchland Power Mist Hand Sanitizer Citrus Grove</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>thand sanitizer o decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-105-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-105-01)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0105-01</NDC11Code>
    <ProductNDC>10237-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Touchland Power Mist Hand Sanitizer Frosted Mint</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10237-106-01</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-106-01)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>10237-0106-01</NDC11Code>
    <ProductNDC>10237-106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Touchland Power Mist Hand Sanitizer Lemon Lime Spritz</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>10237-700-72</NDCCode><ProprietaryName>Simply Saline</ProprietaryName><NonProprietaryName>Benzethonium Chloride 0.13%</NonProprietaryName></NDC><NDC><NDCCode>10237-700-71</NDCCode><ProprietaryName>Simply Saline</ProprietaryName><NonProprietaryName>Benzethonium Chloride 0.13%</NonProprietaryName></NDC><NDC><NDCCode>42507-208-72</NDCCode><ProprietaryName>Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>59779-700-72</NDCCode><ProprietaryName>Anti Diarrheal</ProprietaryName><NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71205-700-72</NDCCode><ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10237-626-72</NDCCode><ProprietaryName>Aim Cavity Protection</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>10237-633-72</NDCCode><ProprietaryName>Aim Cavity Protection</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>10237-644-72</NDCCode><ProprietaryName>Close Up</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>10237-653-72</NDCCode><ProprietaryName>Complete Care Tartar Control</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>10237-655-72</NDCCode><ProprietaryName>Peroxie Care Tartar Control</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>10237-656-72</NDCCode><ProprietaryName>Advance White</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>10237-658-72</NDCCode><ProprietaryName>Advance White Extreme Whitening</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>13811-700-30</NDCCode><ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>44567-700-25</NDCCode><ProprietaryName>Ceftriaxone</ProprietaryName><NonProprietaryName>Ceftriaxone</NonProprietaryName></NDC><NDC><NDCCode>65219-656-10</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphates</NonProprietaryName></NDC><NDC><NDCCode>65219-658-25</NDCCode><ProprietaryName>Potassium Phosphates</ProprietaryName><NonProprietaryName>Potassium Phosphates</NonProprietaryName></NDC><NDC><NDCCode>65862-700-20</NDCCode><ProprietaryName>Cefuroxime Axetil</ProprietaryName><NonProprietaryName>Cefuroxime Axetil</NonProprietaryName></NDC><NDC><NDCCode>65862-700-60</NDCCode><ProprietaryName>Cefuroxime Axetil</ProprietaryName><NonProprietaryName>Cefuroxime Axetil</NonProprietaryName></NDC><NDC><NDCCode>10237-001-00</NDCCode><ProprietaryName>Hero Pore Release Blackhead Clearing</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>10237-002-50</NDCCode><ProprietaryName>Hero Mighty Cleanser</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>10237-003-00</NDCCode><ProprietaryName>Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>10237-004-00</NDCCode><ProprietaryName>Hero Force Shield Superbeam Sunscreen Spf 30 Apricot</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10237-005-50</NDCCode><ProprietaryName>Hero Pore Cleanser</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>10237-100-01</NDCCode><ProprietaryName>Touchland Power Mist Hand Sanitizer Wild Watermelon</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10237-101-01</NDCCode><ProprietaryName>Touchland Power Mist Hand Sanitizer Aloe You</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10237-102-01</NDCCode><ProprietaryName>Touchland Power Mist Hand Sanitizer Berry Bliss</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10237-103-01</NDCCode><ProprietaryName>Touchland Power Mist Hand Sanitizer Blue Sandalwood</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10237-104-01</NDCCode><ProprietaryName>Touchland Power Mist Hand Sanitizer Citrus Grove</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10237-105-01</NDCCode><ProprietaryName>Touchland Power Mist Hand Sanitizer Frosted Mint</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10237-106-01</NDCCode><ProprietaryName>Touchland Power Mist Hand Sanitizer Lemon Lime Spritz</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
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      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
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}
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