{
"NDC": [
{
"NDCCode": "54973-3179-4",
"PackageDescription": "10 POUCH in 1 CARTON (54973-3179-4) > 5 mL in 1 POUCH",
"NDC11Code": "54973-3179-04",
"ProductNDC": "54973-3179",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Complete Cold And Mucus",
"NonProprietaryName": "Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE",
"StrengthNumber": "6; 6; 12; 30; 30; 6; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140701",
"SamplePackage": "N"
},
{
"NDCCode": "36987-3179-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-3179-4)",
"NDC11Code": "36987-3179-04",
"ProductNDC": "36987-3179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yellow Dock",
"NonProprietaryName": "Yellow Dock",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "RUMEX CRISPUS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"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": "71335-3179-4",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (71335-3179-4) ",
"NDC11Code": "71335-3179-04",
"ProductNDC": "71335-3179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217118",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260908",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium trihydrate USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium trihydrate USP is freely soluble in methanol; slightly soluble in ethanol; very slightly soluble in water, pH 7.4 phosphate buffer solution, and acetonitrile. Atorvastatin calcium tablets USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, soya lecithin, talc, titanium dioxide and xanthan gum. Meets USP Dissolution Test 6."
},
{
"NDCCode": "54973-3179-1",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-1) > 118 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3179-01",
"ProductNDC": "54973-3179",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Complete Cold And Mucus",
"NonProprietaryName": "Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE",
"StrengthNumber": "6; 6; 12; 30; 30; 6; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140701",
"SamplePackage": "N",
"IndicationAndUsage": "■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose. ■ cough with expectoration of thick, discolored mucus. ■ runny nose ■ sneezing ■ nasal or chest congestion."
},
{
"NDCCode": "54973-3179-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-2) > 19.8 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3179-02",
"ProductNDC": "54973-3179",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Complete Cold And Mucus",
"NonProprietaryName": "Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE",
"StrengthNumber": "6; 6; 12; 30; 30; 6; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141017",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3179-5",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-5) > 148 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3179-05",
"ProductNDC": "54973-3179",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Complete Cold And Mucus",
"NonProprietaryName": "Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE",
"StrengthNumber": "6; 6; 12; 30; 30; 6; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140701",
"SamplePackage": "N",
"IndicationAndUsage": "■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose. ■ cough with expectoration of thick, discolored mucus. ■ runny nose ■ sneezing ■ nasal or chest congestion."
},
{
"NDCCode": "54973-3285-1",
"PackageDescription": "1 KIT in 1 CARTON (54973-3285-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-1) > 118 mL in 1 BOTTLE, PLASTIC * 118 mL in 1 BOTTLE, PLASTIC (54973-3250-1) ",
"NDC11Code": "54973-3285-01",
"ProductNDC": "54973-3285",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Cold N Mucus Day And Night Value Pack",
"NonProprietaryName": "Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, Silicon Dioxide, Onion, Matricaria Recutita, Arabica Coffee Bean, Goldenseal, Strychnos Nux-vomica Seed, Anemone Pulsatilla, And Sulfur",
"DosageFormName": "KIT",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"Status": "Deprecated",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160610",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3381-1",
"PackageDescription": "1 KIT in 1 CARTON (54973-3381-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3372-2) > 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-1) > 118 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3381-01",
"ProductNDC": "54973-3381",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Kids Cold And Mucus",
"NonProprietaryName": "Euphrasia Stricta,silicon Dioxide, Rumex Crispus Root, Anemone Pulsatilla, Goldenseal, Sodium Chloride, Phosphorus, Onion, Bryonia Alba Root, Matricaria Chamomilla, Arabica Coffee Bean, Calcium Sulfide And Sulfur",
"DosageFormName": "KIT",
"StartMarketingDate": "20180801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N"
},
{
"NDCCode": "48951-3179-3",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (48951-3179-3) ",
"NDC11Code": "48951-3179-03",
"ProductNDC": "48951-3179",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carduus Viscum Special Order",
"NonProprietaryName": "Carduus Viscum Special Order",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "MILK THISTLE; VISCUM ALBUM FRUITING TOP; MAMMAL LIVER",
"StrengthNumber": "3; 4; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "50090-3179-0",
"PackageDescription": "20 TABLET in 1 BOTTLE (50090-3179-0) ",
"NDC11Code": "50090-3179-00",
"ProductNDC": "50090-3179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203824",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171016",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50090-3179-1",
"PackageDescription": "10 TABLET in 1 BOTTLE (50090-3179-1) ",
"NDC11Code": "50090-3179-01",
"ProductNDC": "50090-3179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203824",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171222",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50090-3179-2",
"PackageDescription": "14 TABLET in 1 BOTTLE (50090-3179-2) ",
"NDC11Code": "50090-3179-02",
"ProductNDC": "50090-3179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203824",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50090-3179-3",
"PackageDescription": "28 TABLET in 1 BOTTLE (50090-3179-3) ",
"NDC11Code": "50090-3179-03",
"ProductNDC": "50090-3179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203824",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180329",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50090-3179-5",
"PackageDescription": "1 TABLET in 1 BOTTLE (50090-3179-5) ",
"NDC11Code": "50090-3179-05",
"ProductNDC": "50090-3179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203824",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180313",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.",
"Description": "Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium."
},
{
"NDCCode": "61699-3178-3",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (61699-3178-3) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "61699-3178-03",
"ProductNDC": "61699-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20140612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "US MedSource, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, and 3179 are carbon dioxide gassed and Lists 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2’,6’-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "61699-3182-3",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (61699-3182-3) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "61699-3182-03",
"ProductNDC": "61699-3182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20140614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "US MedSource, LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, and 3179 are carbon dioxide gassed and Lists 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2’,6’-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "54973-0229-2",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-0229-2) ",
"NDC11Code": "54973-0229-02",
"ProductNDC": "54973-0229",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicaid",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19910717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "30; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19910717",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-0229-3",
"PackageDescription": "4 POUCH in 1 CARTON (54973-0229-3) > 4 TABLET, SOLUBLE in 1 POUCH",
"NDC11Code": "54973-0229-03",
"ProductNDC": "54973-0229",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicaid",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19910717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "30; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19910717",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0232-2",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-0232-2) ",
"NDC11Code": "54973-0232-02",
"ProductNDC": "54973-0232",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnisport",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20000428",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20000428",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-0232-3",
"PackageDescription": "4 POUCH in 1 CARTON (54973-0232-3) / 4 TABLET, SOLUBLE in 1 POUCH",
"NDC11Code": "54973-0232-03",
"ProductNDC": "54973-0232",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnisport",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20000428",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20000428",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0600-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0600-4) ",
"NDC11Code": "54973-0600-04",
"ProductNDC": "54973-0600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aconite Napellis",
"NonProprietaryName": "Aconitum Napellus Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ACONITUM NAPELLUS ROOT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0601-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0601-4) ",
"NDC11Code": "54973-0601-04",
"ProductNDC": "54973-0601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allium Cepa",
"NonProprietaryName": "Onion",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ONION",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0602-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0602-4) ",
"NDC11Code": "54973-0602-04",
"ProductNDC": "54973-0602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimonium Tart",
"NonProprietaryName": "Antimony Potassium Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0603-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0603-4) ",
"NDC11Code": "54973-0603-04",
"ProductNDC": "54973-0603",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apis Mellifica",
"NonProprietaryName": "Apis Mellifera",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "APIS MELLIFERA",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0604-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0604-4) ",
"NDC11Code": "54973-0604-04",
"ProductNDC": "54973-0604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Montana",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N",
"IndicationAndUsage": "Bruises or Muscle Soreness."
},
{
"NDCCode": "54973-0605-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0605-4) ",
"NDC11Code": "54973-0605-04",
"ProductNDC": "54973-0605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Album",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N",
"IndicationAndUsage": "BURNING NASAL DISCHARGE OR DIARRHEA."
},
{
"NDCCode": "54973-0606-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0606-4) ",
"NDC11Code": "54973-0606-04",
"ProductNDC": "54973-0606",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Belladonna",
"NonProprietaryName": "Atropa Belladonna Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ATROPA BELLADONNA ROOT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0607-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0607-4) ",
"NDC11Code": "54973-0607-04",
"ProductNDC": "54973-0607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bryonia Alba",
"NonProprietaryName": "Bryonia Alba Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "BRYONIA ALBA ROOT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0609-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0609-4) ",
"NDC11Code": "54973-0609-04",
"ProductNDC": "54973-0609",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cantharis",
"NonProprietaryName": "Lytta Vesicatoria",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "LYTTA VESICATORIA",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0610-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0610-4) ",
"NDC11Code": "54973-0610-04",
"ProductNDC": "54973-0610",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carbo Veg",
"NonProprietaryName": "Activated Charcoal",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ACTIVATED CHARCOAL",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54973-3179-4</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (54973-3179-4) > 5 mL in 1 POUCH</PackageDescription>
<NDC11Code>54973-3179-04</NDC11Code>
<ProductNDC>54973-3179</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Complete Cold And Mucus</ProprietaryName>
<NonProprietaryName>Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 12; 30; 30; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36987-3179-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-3179-4)</PackageDescription>
<NDC11Code>36987-3179-04</NDC11Code>
<ProductNDC>36987-3179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yellow Dock</ProprietaryName>
<NonProprietaryName>Yellow Dock</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>RUMEX CRISPUS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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>71335-3179-4</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (71335-3179-4) </PackageDescription>
<NDC11Code>71335-3179-04</NDC11Code>
<ProductNDC>71335-3179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217118</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium trihydrate USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium trihydrate USP is freely soluble in methanol; slightly soluble in ethanol; very slightly soluble in water, pH 7.4 phosphate buffer solution, and acetonitrile. Atorvastatin calcium tablets USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, soya lecithin, talc, titanium dioxide and xanthan gum. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>54973-3179-1</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-1) > 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3179-01</NDC11Code>
<ProductNDC>54973-3179</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Complete Cold And Mucus</ProprietaryName>
<NonProprietaryName>Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 12; 30; 30; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose. ■ cough with expectoration of thick, discolored mucus. ■ runny nose ■ sneezing ■ nasal or chest congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3179-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-2) > 19.8 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3179-02</NDC11Code>
<ProductNDC>54973-3179</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Complete Cold And Mucus</ProprietaryName>
<NonProprietaryName>Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 12; 30; 30; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3179-5</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-5) > 148 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3179-05</NDC11Code>
<ProductNDC>54973-3179</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Complete Cold And Mucus</ProprietaryName>
<NonProprietaryName>Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6; 6; 12; 30; 30; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose. ■ cough with expectoration of thick, discolored mucus. ■ runny nose ■ sneezing ■ nasal or chest congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3285-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (54973-3285-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-1) > 118 mL in 1 BOTTLE, PLASTIC * 118 mL in 1 BOTTLE, PLASTIC (54973-3250-1) </PackageDescription>
<NDC11Code>54973-3285-01</NDC11Code>
<ProductNDC>54973-3285</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Cold N Mucus Day And Night Value Pack</ProprietaryName>
<NonProprietaryName>Bryonia Alba Root, Euphrasia Stricta, Calcium Sulfide, Sodium Chloride, Phosphorus, Anemone Pulsatilla, Rumex Crispus Root, Silicon Dioxide, Onion, Matricaria Recutita, Arabica Coffee Bean, Goldenseal, Strychnos Nux-vomica Seed, Anemone Pulsatilla, And Sulfur</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3381-1</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (54973-3381-1) * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3372-2) > 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (54973-3179-1) > 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3381-01</NDC11Code>
<ProductNDC>54973-3381</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Kids Cold And Mucus</ProprietaryName>
<NonProprietaryName>Euphrasia Stricta,silicon Dioxide, Rumex Crispus Root, Anemone Pulsatilla, Goldenseal, Sodium Chloride, Phosphorus, Onion, Bryonia Alba Root, Matricaria Chamomilla, Arabica Coffee Bean, Calcium Sulfide And Sulfur</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-3179-3</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (48951-3179-3) </PackageDescription>
<NDC11Code>48951-3179-03</NDC11Code>
<ProductNDC>48951-3179</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carduus Viscum Special Order</ProprietaryName>
<NonProprietaryName>Carduus Viscum Special Order</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>MILK THISTLE; VISCUM ALBUM FRUITING TOP; MAMMAL LIVER</SubstanceName>
<StrengthNumber>3; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-3179-0</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (50090-3179-0) </PackageDescription>
<NDC11Code>50090-3179-00</NDC11Code>
<ProductNDC>50090-3179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203824</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
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<LastUpdate>2026-02-16</LastUpdate>
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<IndicationAndUsage>Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP.</Description>
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<IndicationAndUsage>Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium. FDA approved dissolution test specifications differ from USP.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20180313</StartMarketingDatePackage>
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<IndicationAndUsage>Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: 1 Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis., 2 Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 3 Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis., 4 Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species., 5 Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.</IndicationAndUsage>
<Description>Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin 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 and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium.</Description>
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<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, and 3179 are carbon dioxide gassed and Lists 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2’,6’-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, and 3179 are carbon dioxide gassed and Lists 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2’,6’-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910717</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>30; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0232-2</NDCCode>
<PackageDescription>4 TABLET, SOLUBLE in 1 POUCH (54973-0232-2) </PackageDescription>
<NDC11Code>54973-0232-02</NDC11Code>
<ProductNDC>54973-0232</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnisport</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000428</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000428</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0232-3</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (54973-0232-3) / 4 TABLET, SOLUBLE in 1 POUCH</PackageDescription>
<NDC11Code>54973-0232-03</NDC11Code>
<ProductNDC>54973-0232</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnisport</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000428</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0600-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0600-4) </PackageDescription>
<NDC11Code>54973-0600-04</NDC11Code>
<ProductNDC>54973-0600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aconite Napellis</ProprietaryName>
<NonProprietaryName>Aconitum Napellus Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ACONITUM NAPELLUS ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0601-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0601-4) </PackageDescription>
<NDC11Code>54973-0601-04</NDC11Code>
<ProductNDC>54973-0601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allium Cepa</ProprietaryName>
<NonProprietaryName>Onion</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ONION</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0602-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0602-4) </PackageDescription>
<NDC11Code>54973-0602-04</NDC11Code>
<ProductNDC>54973-0602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antimonium Tart</ProprietaryName>
<NonProprietaryName>Antimony Potassium Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0603-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0603-4) </PackageDescription>
<NDC11Code>54973-0603-04</NDC11Code>
<ProductNDC>54973-0603</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apis Mellifica</ProprietaryName>
<NonProprietaryName>Apis Mellifera</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>APIS MELLIFERA</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0604-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0604-4) </PackageDescription>
<NDC11Code>54973-0604-04</NDC11Code>
<ProductNDC>54973-0604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Montana</ProprietaryName>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bruises or Muscle Soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-0605-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0605-4) </PackageDescription>
<NDC11Code>54973-0605-04</NDC11Code>
<ProductNDC>54973-0605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Album</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BURNING NASAL DISCHARGE OR DIARRHEA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-0606-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0606-4) </PackageDescription>
<NDC11Code>54973-0606-04</NDC11Code>
<ProductNDC>54973-0606</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Belladonna</ProprietaryName>
<NonProprietaryName>Atropa Belladonna Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ATROPA BELLADONNA ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0607-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0607-4) </PackageDescription>
<NDC11Code>54973-0607-04</NDC11Code>
<ProductNDC>54973-0607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bryonia Alba</ProprietaryName>
<NonProprietaryName>Bryonia Alba Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0609-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0609-4) </PackageDescription>
<NDC11Code>54973-0609-04</NDC11Code>
<ProductNDC>54973-0609</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cantharis</ProprietaryName>
<NonProprietaryName>Lytta Vesicatoria</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>LYTTA VESICATORIA</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0610-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0610-4) </PackageDescription>
<NDC11Code>54973-0610-04</NDC11Code>
<ProductNDC>54973-0610</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carbo Veg</ProprietaryName>
<NonProprietaryName>Activated Charcoal</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>