{
"NDC": [
{
"NDCCode": "72934-2091-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-2091-2) ",
"NDC11Code": "72934-2091-02",
"ProductNDC": "72934-2091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyaluronic Acid Sodium Salt 0.5% / Niacinamide 4% / Tretinoin 0.05%",
"NonProprietaryName": "Hyaluronic Acid Sodium Salt 0.5% / Niacinamide 4% / Tretinoin 0.05%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "HYALURONIC ACID; NIACINAMIDE; TRETINOIN",
"StrengthNumber": ".5; 4; .05",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "36987-2091-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2091-2)",
"NDC11Code": "36987-2091-02",
"ProductNDC": "36987-2091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saccharomyces Cerevisiae",
"NonProprietaryName": "Saccharomyces Cerevisiae",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "SACCHAROMYCES CEREVISIAE",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2091-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-2091-2) ",
"NDC11Code": "37662-2091-02",
"ProductNDC": "37662-2091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Silicea",
"NonProprietaryName": "Silicea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221214",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SILICON DIOXIDE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221214",
"SamplePackage": "N"
},
{
"NDCCode": "53002-2091-2",
"PackageDescription": "100 mL in 1 BOTTLE (53002-2091-2) ",
"NDC11Code": "53002-2091-02",
"ProductNDC": "53002-2091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061931",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "63083-2091-2",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (63083-2091-2) ",
"NDC11Code": "63083-2091-02",
"ProductNDC": "63083-2091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Formula Iii Drops",
"ProprietaryNameSuffix": "2091",
"NonProprietaryName": "Pain Formula Iii Drops",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19840815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Professional Complementary Health Formulas",
"SubstanceName": "VALERIAN; DIOSCOREA VILLOSA TUBER; POTASSIUM IODIDE; PULSATILLA MONTANA WHOLE; STRYCHNOS IGNATII SEED; OXALIC ACID; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "1; 3; 3; 4; 5; 6; 6",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19850815",
"SamplePackage": "N"
},
{
"NDCCode": "68745-2091-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (68745-2091-2) > 20 mL in 1 BOTTLE",
"NDC11Code": "68745-2091-02",
"ProductNDC": "68745-2091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Les Beiges",
"ProprietaryNameSuffix": "Sheer Healthy Glow Moisturizing Tint Broad Spectrum Spf 30 Sunscreen Medium Light",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180502",
"EndMarketingDate": "20220630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CHANEL PARFUMS BEAUTE",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "50; 64",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180502",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "71335-2091-2",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-2091-2) ",
"NDC11Code": "71335-2091-02",
"ProductNDC": "71335-2091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076230",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220517",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Black. (See WARNINGS, Head and Neck Angioedema.).",
"Description": "Lisinopril and hydrochlorothiazide tablets combine an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 . 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP, are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10-12.5 containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets 20-12.5 containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and, lisinopril and hydrochlorothiazide tablets 20-25 containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive Ingredients. 10-12.5 Tablets – mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate. 20-12.5 Tablets - mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate, yellow ferric oxide. 20-25 Tablets - mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate, red ferric oxide."
},
{
"NDCCode": "53002-2091-1",
"PackageDescription": "80 mL in 1 BOTTLE (53002-2091-1) ",
"NDC11Code": "53002-2091-01",
"ProductNDC": "53002-2091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061931",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "53002-2091-3",
"PackageDescription": "150 mL in 1 BOTTLE (53002-2091-3) ",
"NDC11Code": "53002-2091-03",
"ProductNDC": "53002-2091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061931",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "72934-1002-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1002-2) ",
"NDC11Code": "72934-1002-02",
"ProductNDC": "72934-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene 0.1% / Benzoyl Peroxide 2.5% / Clindamycin 1%",
"NonProprietaryName": "Adapalene 0.1% / Benzoyl Peroxide 2.5% / Clindamycin 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190510",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; .1; 2.5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE],Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190510",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1003-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1003-2) ",
"NDC11Code": "72934-1003-02",
"ProductNDC": "72934-1003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene 0.1% / Benzoyl Peroxide 2.5% / Niacinamide 4%",
"NonProprietaryName": "Adapalene 0.1% / Benzoyl Peroxide 2.5% / Niacinamide 4%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190510",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE; NIACINAMIDE",
"StrengthNumber": ".1; 2.5; 4",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190510",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1004-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1004-2) ",
"NDC11Code": "72934-1004-02",
"ProductNDC": "72934-1004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene 0.3% / Benzoyl Peroxide 2.5% / Clindamycin 1%",
"NonProprietaryName": "Adapalene 0.3% / Benzoyl Peroxide 2.5% / Clindamycin 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; .3; 2.5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE],Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1005-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1005-2) ",
"NDC11Code": "72934-1005-02",
"ProductNDC": "72934-1005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene 0.3% / Benzoyl Peroxide 2.5% / Niacinamide 4%",
"NonProprietaryName": "Adapalene 0.3% / Benzoyl Peroxide 2.5% / Niacinamide 4%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "NIACINAMIDE; ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "4; .3; 2.5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1006-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1006-2) ",
"NDC11Code": "72934-1006-02",
"ProductNDC": "72934-1006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene 0.3% / Niacinamide 4%",
"NonProprietaryName": "Adapalene 0.3% / Niacinamide 4%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190510",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "ADAPALENE; NIACINAMIDE",
"StrengthNumber": ".3; 4",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190510",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1011-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1011-2) ",
"NDC11Code": "72934-1011-02",
"ProductNDC": "72934-1011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imiquimod 5% / Levocetirizine Dihydrochloride 1% / Tretinoin 0.05%",
"NonProprietaryName": "Imiquimod 5% / Levocetirizine Dihydrochloride 1% / Tretinoin 0.05%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "TRETINOIN; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE",
"StrengthNumber": ".025; 2.5; 1; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; GBq/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1012-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1012-2) ",
"NDC11Code": "72934-1012-02",
"ProductNDC": "72934-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 2.5%, Clindamycin Phosphate 1%, Niacinamide 2% / Tretinoin 0.05%",
"NonProprietaryName": "Benzoyl Peroxide 2.5%, Clindamycin Phosphate 1%, Niacinamide 2% / Tretinoin 0.05%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "NIACINAMIDE; TRETINOIN; CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
"StrengthNumber": "2; .05; 1; 2.5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1013-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1013-2) ",
"NDC11Code": "72934-1013-02",
"ProductNDC": "72934-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 4%",
"NonProprietaryName": "Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 4%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BENZOYL PEROXIDE; NIACINAMIDE; CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "2.5; 4; 1",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1014-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1014-2) ",
"NDC11Code": "72934-1014-02",
"ProductNDC": "72934-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190511",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE; SPIRONOLACTONE",
"StrengthNumber": "5; 1; 2; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190511",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1015-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1015-2) ",
"NDC11Code": "72934-1015-02",
"ProductNDC": "72934-1015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.025%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; TRETINOIN; NIACINAMIDE; SPIRONOLACTONE",
"StrengthNumber": "5; 1; .025; 2; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Retinoid [EPC],Retinoids [CS],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1016-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1016-2) ",
"NDC11Code": "72934-1016-02",
"ProductNDC": "72934-1016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.05%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.05%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190503",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida LLC",
"SubstanceName": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; TRETINOIN; NIACINAMIDE; SPIRONOLACTONE",
"StrengthNumber": "5; 1; .05; 2; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Retinoid [EPC],Retinoids [CS],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190503",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1017-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1017-2) ",
"NDC11Code": "72934-1017-02",
"ProductNDC": "72934-1017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.05%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.05%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "NIACINAMIDE; TRETINOIN; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "2; .05; 5; 1",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1018-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1018-2) ",
"NDC11Code": "72934-1018-02",
"ProductNDC": "72934-1018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.1%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BENZOYL PEROXIDE; NIACINAMIDE; CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "5; 2; 1; .1",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE],Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1019-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1019-2) ",
"NDC11Code": "72934-1019-02",
"ProductNDC": "72934-1019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 4%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 4%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE",
"StrengthNumber": "5; 1; 4",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1020-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1020-2) ",
"NDC11Code": "72934-1020-02",
"ProductNDC": "72934-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Clindamycin1% / Niacinamide 2% / Tretinoin 0.025%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Clindamycin1% / Niacinamide 2% / Tretinoin 0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BENZOYL PEROXIDE; NIACINAMIDE; TRETINOIN; CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "5; 2; .025; 1",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1021-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1021-2) ",
"NDC11Code": "72934-1021-02",
"ProductNDC": "72934-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 5% / Niacinamide 2% / Tretinoin 0.025%",
"NonProprietaryName": "Benzoyl Peroxide 5% / Niacinamide 2% / Tretinoin 0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190503",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus, Florida, LLC",
"SubstanceName": "BENZOYL PEROXIDE; NIACINAMIDE; TRETINOIN",
"StrengthNumber": "5; 2; .025",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190503",
"SamplePackage": "N"
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{
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"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1022-2) ",
"NDC11Code": "72934-1022-02",
"ProductNDC": "72934-1022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.025%",
"NonProprietaryName": "Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190522",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "TRETINOIN; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE",
"StrengthNumber": ".025; 2.5; 1; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190522",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1027-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1027-2) ",
"NDC11Code": "72934-1027-02",
"ProductNDC": "72934-1027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine Tartrate 0.25% / Potassium Azeloyl Diglycinate 8%",
"NonProprietaryName": "Brimonidine Tartrate 0.25% / Potassium Azeloyl Diglycinate 8%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190516",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BRIMONIDINE TARTRATE",
"StrengthNumber": ".25",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190516",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1028-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1028-2) ",
"NDC11Code": "72934-1028-02",
"ProductNDC": "72934-1028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine Tartrate 0.25% / Ivermectin 1% / Metronidazole 1% / Niacinamide 4%",
"NonProprietaryName": "Brimonidine Tartrate 0.25% / Ivermectin 1% / Metronidazole 1% / Niacinamide 4%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190516",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "BRIMONIDINE TARTRATE; METRONIDAZOLE; NIACINAMIDE; IVERMECTIN",
"StrengthNumber": ".25; 1; 4; 1",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS],Antiparasitic [EPC],Pediculicide [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190516",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1042-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1042-2) ",
"NDC11Code": "72934-1042-02",
"ProductNDC": "72934-1042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox 3%",
"NonProprietaryName": "Ciclopirox 3%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "CICLOPIROX OLAMINE",
"StrengthNumber": "3",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N"
},
{
"NDCCode": "72934-1047-2",
"PackageDescription": "30 g in 1 BOTTLE, PUMP (72934-1047-2) ",
"NDC11Code": "72934-1047-02",
"ProductNDC": "72934-1047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cimetidine 5% / Ibuprofen 2% / Salicylic Acid 17%",
"NonProprietaryName": "Cimetidine 5% / Ibuprofen 2% / Salicylic Acid 17%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190517",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sincerus Florida, LLC",
"SubstanceName": "IBUPROFEN; CIMETIDINE; SALICYLIC ACID",
"StrengthNumber": "2; 5; 17",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190517",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>72934-2091-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-2091-2) </PackageDescription>
<NDC11Code>72934-2091-02</NDC11Code>
<ProductNDC>72934-2091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyaluronic Acid Sodium Salt 0.5% / Niacinamide 4% / Tretinoin 0.05%</ProprietaryName>
<NonProprietaryName>Hyaluronic Acid Sodium Salt 0.5% / Niacinamide 4% / Tretinoin 0.05%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>HYALURONIC ACID; NIACINAMIDE; TRETINOIN</SubstanceName>
<StrengthNumber>.5; 4; .05</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36987-2091-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2091-2)</PackageDescription>
<NDC11Code>36987-2091-02</NDC11Code>
<ProductNDC>36987-2091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName>
<NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>SACCHAROMYCES CEREVISIAE</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2091-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-2091-2) </PackageDescription>
<NDC11Code>37662-2091-02</NDC11Code>
<ProductNDC>37662-2091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Silicea</ProprietaryName>
<NonProprietaryName>Silicea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SILICON DIOXIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-2091-2</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (53002-2091-2) </PackageDescription>
<NDC11Code>53002-2091-02</NDC11Code>
<ProductNDC>53002-2091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061931</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>63083-2091-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-2091-2) </PackageDescription>
<NDC11Code>63083-2091-02</NDC11Code>
<ProductNDC>63083-2091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Formula Iii Drops</ProprietaryName>
<ProprietaryNameSuffix>2091</ProprietaryNameSuffix>
<NonProprietaryName>Pain Formula Iii Drops</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Professional Complementary Health Formulas</LabelerName>
<SubstanceName>VALERIAN; DIOSCOREA VILLOSA TUBER; POTASSIUM IODIDE; PULSATILLA MONTANA WHOLE; STRYCHNOS IGNATII SEED; OXALIC ACID; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>1; 3; 3; 4; 5; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68745-2091-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68745-2091-2) > 20 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68745-2091-02</NDC11Code>
<ProductNDC>68745-2091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Les Beiges</ProprietaryName>
<ProprietaryNameSuffix>Sheer Healthy Glow Moisturizing Tint Broad Spectrum Spf 30 Sunscreen Medium Light</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180502</StartMarketingDate>
<EndMarketingDate>20220630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CHANEL PARFUMS BEAUTE</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>50; 64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180502</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-2091-2</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-2091-2) </PackageDescription>
<NDC11Code>71335-2091-02</NDC11Code>
<ProductNDC>71335-2091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076230</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>20; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Black. (See WARNINGS, Head and Neck Angioedema.).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablets combine an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5 . 2H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP, are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10-12.5 containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets 20-12.5 containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and, lisinopril and hydrochlorothiazide tablets 20-25 containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive Ingredients. 10-12.5 Tablets – mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate. 20-12.5 Tablets - mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate, yellow ferric oxide. 20-25 Tablets - mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate, red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>53002-2091-1</NDCCode>
<PackageDescription>80 mL in 1 BOTTLE (53002-2091-1) </PackageDescription>
<NDC11Code>53002-2091-01</NDC11Code>
<ProductNDC>53002-2091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061931</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>53002-2091-3</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE (53002-2091-3) </PackageDescription>
<NDC11Code>53002-2091-03</NDC11Code>
<ProductNDC>53002-2091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061931</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae., 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis., 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli., 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin, USP molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>72934-1002-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1002-2) </PackageDescription>
<NDC11Code>72934-1002-02</NDC11Code>
<ProductNDC>72934-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene 0.1% / Benzoyl Peroxide 2.5% / Clindamycin 1%</ProprietaryName>
<NonProprietaryName>Adapalene 0.1% / Benzoyl Peroxide 2.5% / Clindamycin 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190510</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; .1; 2.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE],Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1003-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1003-2) </PackageDescription>
<NDC11Code>72934-1003-02</NDC11Code>
<ProductNDC>72934-1003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene 0.1% / Benzoyl Peroxide 2.5% / Niacinamide 4%</ProprietaryName>
<NonProprietaryName>Adapalene 0.1% / Benzoyl Peroxide 2.5% / Niacinamide 4%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190510</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE; NIACINAMIDE</SubstanceName>
<StrengthNumber>.1; 2.5; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1004-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1004-2) </PackageDescription>
<NDC11Code>72934-1004-02</NDC11Code>
<ProductNDC>72934-1004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene 0.3% / Benzoyl Peroxide 2.5% / Clindamycin 1%</ProprietaryName>
<NonProprietaryName>Adapalene 0.3% / Benzoyl Peroxide 2.5% / Clindamycin 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; .3; 2.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE],Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1005-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1005-2) </PackageDescription>
<NDC11Code>72934-1005-02</NDC11Code>
<ProductNDC>72934-1005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene 0.3% / Benzoyl Peroxide 2.5% / Niacinamide 4%</ProprietaryName>
<NonProprietaryName>Adapalene 0.3% / Benzoyl Peroxide 2.5% / Niacinamide 4%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>NIACINAMIDE; ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>4; .3; 2.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1006-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1006-2) </PackageDescription>
<NDC11Code>72934-1006-02</NDC11Code>
<ProductNDC>72934-1006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene 0.3% / Niacinamide 4%</ProprietaryName>
<NonProprietaryName>Adapalene 0.3% / Niacinamide 4%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190510</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>ADAPALENE; NIACINAMIDE</SubstanceName>
<StrengthNumber>.3; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1011-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1011-2) </PackageDescription>
<NDC11Code>72934-1011-02</NDC11Code>
<ProductNDC>72934-1011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imiquimod 5% / Levocetirizine Dihydrochloride 1% / Tretinoin 0.05%</ProprietaryName>
<NonProprietaryName>Imiquimod 5% / Levocetirizine Dihydrochloride 1% / Tretinoin 0.05%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>TRETINOIN; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE</SubstanceName>
<StrengthNumber>.025; 2.5; 1; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; GBq/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1012-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1012-2) </PackageDescription>
<NDC11Code>72934-1012-02</NDC11Code>
<ProductNDC>72934-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 2.5%, Clindamycin Phosphate 1%, Niacinamide 2% / Tretinoin 0.05%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 2.5%, Clindamycin Phosphate 1%, Niacinamide 2% / Tretinoin 0.05%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>NIACINAMIDE; TRETINOIN; CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2; .05; 1; 2.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1013-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1013-2) </PackageDescription>
<NDC11Code>72934-1013-02</NDC11Code>
<ProductNDC>72934-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 4%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 4%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; NIACINAMIDE; CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>2.5; 4; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1014-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1014-2) </PackageDescription>
<NDC11Code>72934-1014-02</NDC11Code>
<ProductNDC>72934-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE; SPIRONOLACTONE</SubstanceName>
<StrengthNumber>5; 1; 2; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1015-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1015-2) </PackageDescription>
<NDC11Code>72934-1015-02</NDC11Code>
<ProductNDC>72934-1015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.025%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; TRETINOIN; NIACINAMIDE; SPIRONOLACTONE</SubstanceName>
<StrengthNumber>5; 1; .025; 2; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Retinoid [EPC],Retinoids [CS],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1016-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1016-2) </PackageDescription>
<NDC11Code>72934-1016-02</NDC11Code>
<ProductNDC>72934-1016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.05%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Spironolactone 2% / Tretinoin 0.05%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190503</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; TRETINOIN; NIACINAMIDE; SPIRONOLACTONE</SubstanceName>
<StrengthNumber>5; 1; .05; 2; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Retinoid [EPC],Retinoids [CS],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1017-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1017-2) </PackageDescription>
<NDC11Code>72934-1017-02</NDC11Code>
<ProductNDC>72934-1017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.05%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.05%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>NIACINAMIDE; TRETINOIN; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>2; .05; 5; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1018-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1018-2) </PackageDescription>
<NDC11Code>72934-1018-02</NDC11Code>
<ProductNDC>72934-1018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.1%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; NIACINAMIDE; CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>5; 2; 1; .1</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE],Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1019-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1019-2) </PackageDescription>
<NDC11Code>72934-1019-02</NDC11Code>
<ProductNDC>72934-1019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 4%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Clindamycin 1% / Niacinamide 4%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE</SubstanceName>
<StrengthNumber>5; 1; 4</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1020-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1020-2) </PackageDescription>
<NDC11Code>72934-1020-02</NDC11Code>
<ProductNDC>72934-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Clindamycin1% / Niacinamide 2% / Tretinoin 0.025%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Clindamycin1% / Niacinamide 2% / Tretinoin 0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; NIACINAMIDE; TRETINOIN; CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>5; 2; .025; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1021-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1021-2) </PackageDescription>
<NDC11Code>72934-1021-02</NDC11Code>
<ProductNDC>72934-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 5% / Niacinamide 2% / Tretinoin 0.025%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 5% / Niacinamide 2% / Tretinoin 0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190503</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus, Florida, LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE; NIACINAMIDE; TRETINOIN</SubstanceName>
<StrengthNumber>5; 2; .025</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1022-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1022-2) </PackageDescription>
<NDC11Code>72934-1022-02</NDC11Code>
<ProductNDC>72934-1022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.025%</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide 2.5% / Clindamycin 1% / Niacinamide 2% / Tretinoin 0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190522</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>TRETINOIN; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE; NIACINAMIDE</SubstanceName>
<StrengthNumber>.025; 2.5; 1; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS],Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1027-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1027-2) </PackageDescription>
<NDC11Code>72934-1027-02</NDC11Code>
<ProductNDC>72934-1027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine Tartrate 0.25% / Potassium Azeloyl Diglycinate 8%</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate 0.25% / Potassium Azeloyl Diglycinate 8%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190516</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1028-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1028-2) </PackageDescription>
<NDC11Code>72934-1028-02</NDC11Code>
<ProductNDC>72934-1028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine Tartrate 0.25% / Ivermectin 1% / Metronidazole 1% / Niacinamide 4%</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate 0.25% / Ivermectin 1% / Metronidazole 1% / Niacinamide 4%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190516</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE; METRONIDAZOLE; NIACINAMIDE; IVERMECTIN</SubstanceName>
<StrengthNumber>.25; 1; 4; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS],Antiparasitic [EPC],Pediculicide [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1042-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1042-2) </PackageDescription>
<NDC11Code>72934-1042-02</NDC11Code>
<ProductNDC>72934-1042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox 3%</ProprietaryName>
<NonProprietaryName>Ciclopirox 3%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>CICLOPIROX OLAMINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72934-1047-2</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PUMP (72934-1047-2) </PackageDescription>
<NDC11Code>72934-1047-02</NDC11Code>
<ProductNDC>72934-1047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cimetidine 5% / Ibuprofen 2% / Salicylic Acid 17%</ProprietaryName>
<NonProprietaryName>Cimetidine 5% / Ibuprofen 2% / Salicylic Acid 17%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sincerus Florida, LLC</LabelerName>
<SubstanceName>IBUPROFEN; CIMETIDINE; SALICYLIC ACID</SubstanceName>
<StrengthNumber>2; 5; 17</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>