{
"NDC": [
{
"NDCCode": "57955-5061-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-5061-2)",
"NDC11Code": "57955-5061-02",
"ProductNDC": "57955-5061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blood And Kidney Detox",
"NonProprietaryName": "Arsenicum Album, Baptisia Tinctoria, Carbo Vegetabilis, Chininum Sulphuricum, Cinchona Officinalis, Conium Maculatum, Echinacea Purpurea, Ferrum Metallicum, Hydrastis Canadensis, Kali Chloricum, Mercurius Corrosivus And Serum Anguillae",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110626",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ACTIVATED CHARCOAL; QUININE SULFATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; IRON; GOLDENSEAL; POTASSIUM CHLORATE; MERCURIC CHLORIDE; ANGUILLA ROSTRATA BLOOD SERUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses a natural aid to assist the blood and kidneys with the normal process of detoxification and drainage."
},
{
"NDCCode": "48951-5061-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-5061-2) ",
"NDC11Code": "48951-5061-02",
"ProductNDC": "48951-5061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hypericum Bryophyllum",
"NonProprietaryName": "Hypericum Bryophyllum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "KALANCHOE DAIGREMONTIANA LEAF; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MILK THISTLE; ST. JOHN'S WORT",
"StrengthNumber": "2; 6; 6; 1",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "68210-5061-1",
"PackageDescription": "2 BAG in 1 BOX (68210-5061-1) / 1500 CAPSULE, LIQUID FILLED in 1 BAG",
"NDC11Code": "68210-5061-01",
"ProductNDC": "68210-5061",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr ,guaifenesin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"StartMarketingDate": "20250625",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Prodose, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "325; 10; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-28",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "25-JUN-25"
},
{
"NDCCode": "68554-5061-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (68554-5061-2) > 500 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "68554-5061-02",
"ProductNDC": "68554-5061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204097",
"LabelerName": "Hetero Labs Limited",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "0093-5061-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0093-5061-01) ",
"NDC11Code": "00093-5061-01",
"ProductNDC": "0093-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088618",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121009",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide and triacetin."
},
{
"NDCCode": "0093-5061-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0093-5061-05) ",
"NDC11Code": "00093-5061-05",
"ProductNDC": "0093-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088618",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121010",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide and triacetin."
},
{
"NDCCode": "0093-5061-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (0093-5061-10) ",
"NDC11Code": "00093-5061-10",
"ProductNDC": "0093-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088618",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121011",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide and triacetin."
},
{
"NDCCode": "0603-5061-21",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5061-21) ",
"NDC11Code": "00603-5061-21",
"ProductNDC": "0603-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040226",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19981231",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: black iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. Its structural formula is."
},
{
"NDCCode": "0603-5061-28",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5061-28) ",
"NDC11Code": "00603-5061-28",
"ProductNDC": "0603-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040226",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19981231",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: black iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. Its structural formula is."
},
{
"NDCCode": "0781-5061-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5061-01) ",
"NDC11Code": "00781-5061-01",
"ProductNDC": "0781-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065228",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "875",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050713",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat.",
"Description": "Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg of amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients in each 500 mg or 875 mg tablet: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
},
{
"NDCCode": "0781-5061-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (0781-5061-20) ",
"NDC11Code": "00781-5061-20",
"ProductNDC": "0781-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065228",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "875",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050713",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat.",
"Description": "Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg of amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients in each 500 mg or 875 mg tablet: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
},
{
"NDCCode": "10267-5061-4",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (10267-5061-4) ",
"NDC11Code": "10267-5061-04",
"ProductNDC": "10267-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213474",
"LabelerName": "Contract Pharmacal Corp.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210124",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride Capsules, USP include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that Doxepin Hydrochloride Capsules, USP is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, Doxepin Hydrochloride Capsules, USP are not recommended for use in children under 12 years of age."
},
{
"NDCCode": "10267-5061-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (10267-5061-9) ",
"NDC11Code": "10267-5061-09",
"ProductNDC": "10267-5061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213474",
"LabelerName": "Contract Pharmacal Corp.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210124",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride Capsules, USP include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that Doxepin Hydrochloride Capsules, USP is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, Doxepin Hydrochloride Capsules, USP are not recommended for use in children under 12 years of age."
},
{
"NDCCode": "57955-0001-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0001-2)",
"NDC11Code": "57955-0001-02",
"ProductNDC": "57955-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eating Disorders",
"NonProprietaryName": "Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc",
"SubstanceName": "ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders."
},
{
"NDCCode": "57955-0002-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0002-2)",
"NDC11Code": "57955-0002-02",
"ProductNDC": "57955-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Birth Ease",
"NonProprietaryName": "Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache."
},
{
"NDCCode": "57955-0003-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0003-2)",
"NDC11Code": "57955-0003-02",
"ProductNDC": "57955-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Breast Cyst And Discomforts",
"NonProprietaryName": "Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing."
},
{
"NDCCode": "57955-0004-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0004-2)",
"NDC11Code": "57955-0004-02",
"ProductNDC": "57955-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menstrual Cramps And Irregularities",
"NonProprietaryName": "Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow."
},
{
"NDCCode": "57955-0005-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0005-2)",
"NDC11Code": "57955-0005-02",
"ProductNDC": "57955-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferticare",
"NonProprietaryName": "Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse."
},
{
"NDCCode": "57955-0008-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0008-2)",
"NDC11Code": "57955-0008-02",
"ProductNDC": "57955-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Morning Sickness",
"NonProprietaryName": "Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity."
},
{
"NDCCode": "57955-0010-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0010-2)",
"NDC11Code": "57955-0010-02",
"ProductNDC": "57955-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Strengthener",
"NonProprietaryName": "Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140421",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness ."
},
{
"NDCCode": "57955-0011-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0011-2)",
"NDC11Code": "57955-0011-02",
"ProductNDC": "57955-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prostate Strengthener",
"NonProprietaryName": "Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence."
},
{
"NDCCode": "57955-0012-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0012-2)",
"NDC11Code": "57955-0012-02",
"ProductNDC": "57955-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bed Wetting Prevention",
"NonProprietaryName": "Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep.."
},
{
"NDCCode": "57955-0015-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0015-2)",
"NDC11Code": "57955-0015-02",
"ProductNDC": "57955-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Attention And Learning Enhancement",
"NonProprietaryName": "Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140528",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57955-0016-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0016-2)",
"NDC11Code": "57955-0016-02",
"ProductNDC": "57955-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Paraclenz",
"NonProprietaryName": "Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods."
},
{
"NDCCode": "57955-0017-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0017-2)",
"NDC11Code": "57955-0017-02",
"ProductNDC": "57955-0017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tonsilcure",
"NonProprietaryName": "Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous."
},
{
"NDCCode": "57955-0018-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0018-2)",
"NDC11Code": "57955-0018-02",
"ProductNDC": "57955-0018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teething",
"NonProprietaryName": "Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly."
},
{
"NDCCode": "57955-0019-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0019-2)",
"NDC11Code": "57955-0019-02",
"ProductNDC": "57955-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation Relief",
"NonProprietaryName": "Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160627",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache."
},
{
"NDCCode": "57955-0020-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0020-2)",
"NDC11Code": "57955-0020-02",
"ProductNDC": "57955-0020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea Relief",
"NonProprietaryName": "Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140508",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of diarrhea: loose and watery stools, cramps, gas and bloating, mucus in stools, jelly-like stool, sudden evacuation, intestinal gurgling, involuntary stools, diarrhea caused by certain foods or emotional excitement."
},
{
"NDCCode": "57955-0021-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0021-2)",
"NDC11Code": "57955-0021-02",
"ProductNDC": "57955-0021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gout Symptom Relief",
"NonProprietaryName": "Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains."
},
{
"NDCCode": "57955-0022-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0022-2)",
"NDC11Code": "57955-0022-02",
"ProductNDC": "57955-0022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburn Relief",
"NonProprietaryName": "Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptomatic relief of: acid reflux, burning pain, sour stomach, belching, indigestion, nausea, stomach spasms, stomach distention."
}
]
}
{"NDC":[{"NDCCode":"57955-5061-2","ProprietaryName":"Blood And Kidney Detox","NonProprietaryName":"Arsenicum Album, Baptisia Tinctoria, Carbo Vegetabilis, Chininum Sulphuricum, Cinchona Officinalis, Conium Maculatum, Echinacea Purpurea, Ferrum Metallicum, Hydrastis Canadensis, Kali Chloricum, Mercurius Corrosivus And Serum Anguillae"},{"NDCCode":"48951-5061-2","ProprietaryName":"Hypericum Bryophyllum","NonProprietaryName":"Hypericum Bryophyllum"},{"NDCCode":"68210-5061-1","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr ,guaifenesin"},{"NDCCode":"68554-5061-2","ProprietaryName":"Fexofenadine Hydrochloride","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"0093-5061-01","ProprietaryName":"Hydroxyzine Hydrochloride","NonProprietaryName":"Hydroxyzine Hydrochloride"},{"NDCCode":"0093-5061-05","ProprietaryName":"Hydroxyzine Hydrochloride","NonProprietaryName":"Hydroxyzine Hydrochloride"},{"NDCCode":"0093-5061-10","ProprietaryName":"Hydroxyzine Hydrochloride","NonProprietaryName":"Hydroxyzine Hydrochloride"},{"NDCCode":"0603-5061-21","ProprietaryName":"Perphenazine","NonProprietaryName":"Perphenazine"},{"NDCCode":"0603-5061-28","ProprietaryName":"Perphenazine","NonProprietaryName":"Perphenazine"},{"NDCCode":"0781-5061-01","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"0781-5061-20","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"10267-5061-4","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"10267-5061-9","ProprietaryName":"Doxepin Hydrochloride","NonProprietaryName":"Doxepin Hydrochloride"},{"NDCCode":"57955-0001-2","ProprietaryName":"Eating Disorders","NonProprietaryName":"Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album"},{"NDCCode":"57955-0002-2","ProprietaryName":"Birth Ease","NonProprietaryName":"Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus"},{"NDCCode":"57955-0003-2","ProprietaryName":"Breast Cyst And Discomforts","NonProprietaryName":"Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea"},{"NDCCode":"57955-0004-2","ProprietaryName":"Menstrual Cramps And Irregularities","NonProprietaryName":"Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum"},{"NDCCode":"57955-0005-2","ProprietaryName":"Ferticare","NonProprietaryName":"Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia"},{"NDCCode":"57955-0008-2","ProprietaryName":"Morning Sickness","NonProprietaryName":"Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum"},{"NDCCode":"57955-0010-2","ProprietaryName":"Male Strengthener","NonProprietaryName":"Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum"},{"NDCCode":"57955-0011-2","ProprietaryName":"Prostate Strengthener","NonProprietaryName":"Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum"},{"NDCCode":"57955-0012-2","ProprietaryName":"Bed Wetting Prevention","NonProprietaryName":"Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia"},{"NDCCode":"57955-0015-2","ProprietaryName":"Attention And Learning Enhancement","NonProprietaryName":"Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis"},{"NDCCode":"57955-0016-2","ProprietaryName":"Paraclenz","NonProprietaryName":"Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale"},{"NDCCode":"57955-0017-2","ProprietaryName":"Tonsilcure","NonProprietaryName":"Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea"},{"NDCCode":"57955-0018-2","ProprietaryName":"Teething","NonProprietaryName":"Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum"},{"NDCCode":"57955-0019-2","ProprietaryName":"Constipation Relief","NonProprietaryName":"Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia"},{"NDCCode":"57955-0020-2","ProprietaryName":"Diarrhea Relief","NonProprietaryName":"Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album"},{"NDCCode":"57955-0021-2","ProprietaryName":"Gout Symptom Relief","NonProprietaryName":"Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens"},{"NDCCode":"57955-0022-2","ProprietaryName":"Heartburn Relief","NonProprietaryName":"Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>57955-5061-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-5061-2)</PackageDescription>
<NDC11Code>57955-5061-02</NDC11Code>
<ProductNDC>57955-5061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blood And Kidney Detox</ProprietaryName>
<NonProprietaryName>Arsenicum Album, Baptisia Tinctoria, Carbo Vegetabilis, Chininum Sulphuricum, Cinchona Officinalis, Conium Maculatum, Echinacea Purpurea, Ferrum Metallicum, Hydrastis Canadensis, Kali Chloricum, Mercurius Corrosivus And Serum Anguillae</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110626</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ACTIVATED CHARCOAL; QUININE SULFATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; IRON; GOLDENSEAL; POTASSIUM CHLORATE; MERCURIC CHLORIDE; ANGUILLA ROSTRATA BLOOD SERUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses a natural aid to assist the blood and kidneys with the normal process of detoxification and drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>48951-5061-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-5061-2) </PackageDescription>
<NDC11Code>48951-5061-02</NDC11Code>
<ProductNDC>48951-5061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hypericum Bryophyllum</ProprietaryName>
<NonProprietaryName>Hypericum Bryophyllum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>KALANCHOE DAIGREMONTIANA LEAF; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MILK THISTLE; ST. JOHN'S WORT</SubstanceName>
<StrengthNumber>2; 6; 6; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68210-5061-1</NDCCode>
<PackageDescription>2 BAG in 1 BOX (68210-5061-1) / 1500 CAPSULE, LIQUID FILLED in 1 BAG</PackageDescription>
<NDC11Code>68210-5061-01</NDC11Code>
<ProductNDC>68210-5061</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr ,guaifenesin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<StartMarketingDate>20250625</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Prodose, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>325; 10; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-28</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-JUN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68554-5061-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68554-5061-2) > 500 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>68554-5061-02</NDC11Code>
<ProductNDC>68554-5061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204097</ApplicationNumber>
<LabelerName>Hetero Labs Limited</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0093-5061-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0093-5061-01) </PackageDescription>
<NDC11Code>00093-5061-01</NDC11Code>
<ProductNDC>0093-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088618</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0093-5061-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0093-5061-05) </PackageDescription>
<NDC11Code>00093-5061-05</NDC11Code>
<ProductNDC>0093-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088618</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0093-5061-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0093-5061-10) </PackageDescription>
<NDC11Code>00093-5061-10</NDC11Code>
<ProductNDC>0093-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088618</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0603-5061-21</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5061-21) </PackageDescription>
<NDC11Code>00603-5061-21</NDC11Code>
<ProductNDC>0603-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040226</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: black iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0603-5061-28</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5061-28) </PackageDescription>
<NDC11Code>00603-5061-28</NDC11Code>
<ProductNDC>0603-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040226</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: black iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0781-5061-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0781-5061-01) </PackageDescription>
<NDC11Code>00781-5061-01</NDC11Code>
<ProductNDC>0781-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065228</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>875</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat.</IndicationAndUsage>
<Description>Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg of amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients in each 500 mg or 875 mg tablet: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
</NDC>
<NDC>
<NDCCode>0781-5061-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (0781-5061-20) </PackageDescription>
<NDC11Code>00781-5061-20</NDC11Code>
<ProductNDC>0781-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065228</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>875</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat.</IndicationAndUsage>
<Description>Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg of amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients in each 500 mg or 875 mg tablet: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
</NDC>
<NDC>
<NDCCode>10267-5061-4</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (10267-5061-4) </PackageDescription>
<NDC11Code>10267-5061-04</NDC11Code>
<ProductNDC>10267-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213474</ApplicationNumber>
<LabelerName>Contract Pharmacal Corp.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride Capsules, USP include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that Doxepin Hydrochloride Capsules, USP is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, Doxepin Hydrochloride Capsules, USP are not recommended for use in children under 12 years of age.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10267-5061-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (10267-5061-9) </PackageDescription>
<NDC11Code>10267-5061-09</NDC11Code>
<ProductNDC>10267-5061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213474</ApplicationNumber>
<LabelerName>Contract Pharmacal Corp.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride Capsules, USP include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that Doxepin Hydrochloride Capsules, USP is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, Doxepin Hydrochloride Capsules, USP are not recommended for use in children under 12 years of age.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0001-2)</PackageDescription>
<NDC11Code>57955-0001-02</NDC11Code>
<ProductNDC>57955-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eating Disorders</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0002-2)</PackageDescription>
<NDC11Code>57955-0002-02</NDC11Code>
<ProductNDC>57955-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Birth Ease</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0003-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0003-2)</PackageDescription>
<NDC11Code>57955-0003-02</NDC11Code>
<ProductNDC>57955-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Breast Cyst And Discomforts</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0004-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0004-2)</PackageDescription>
<NDC11Code>57955-0004-02</NDC11Code>
<ProductNDC>57955-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menstrual Cramps And Irregularities</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0005-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0005-2)</PackageDescription>
<NDC11Code>57955-0005-02</NDC11Code>
<ProductNDC>57955-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferticare</ProprietaryName>
<NonProprietaryName>Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0008-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0008-2)</PackageDescription>
<NDC11Code>57955-0008-02</NDC11Code>
<ProductNDC>57955-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Morning Sickness</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0010-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0010-2)</PackageDescription>
<NDC11Code>57955-0010-02</NDC11Code>
<ProductNDC>57955-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Strengthener</ProprietaryName>
<NonProprietaryName>Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140421</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0011-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0011-2)</PackageDescription>
<NDC11Code>57955-0011-02</NDC11Code>
<ProductNDC>57955-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prostate Strengthener</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140331</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0012-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0012-2)</PackageDescription>
<NDC11Code>57955-0012-02</NDC11Code>
<ProductNDC>57955-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bed Wetting Prevention</ProprietaryName>
<NonProprietaryName>Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep..</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0015-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0015-2)</PackageDescription>
<NDC11Code>57955-0015-02</NDC11Code>
<ProductNDC>57955-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Attention And Learning Enhancement</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140528</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57955-0016-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0016-2)</PackageDescription>
<NDC11Code>57955-0016-02</NDC11Code>
<ProductNDC>57955-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Paraclenz</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0017-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0017-2)</PackageDescription>
<NDC11Code>57955-0017-02</NDC11Code>
<ProductNDC>57955-0017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tonsilcure</ProprietaryName>
<NonProprietaryName>Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0018-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0018-2)</PackageDescription>
<NDC11Code>57955-0018-02</NDC11Code>
<ProductNDC>57955-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Teething</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0019-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0019-2)</PackageDescription>
<NDC11Code>57955-0019-02</NDC11Code>
<ProductNDC>57955-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation Relief</ProprietaryName>
<NonProprietaryName>Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160627</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0020-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0020-2)</PackageDescription>
<NDC11Code>57955-0020-02</NDC11Code>
<ProductNDC>57955-0020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea Relief</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Chamomilla, Cinchona Officinalis, Colocynthis, Croton Tigium, Cuprum Arsenicosum, Gelsemium Sempervirens, Ipecacuanha, Nux Vomica, Phosphoricum Acidum, Podophyllum Peltatum, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of diarrhea: loose and watery stools, cramps, gas and bloating, mucus in stools, jelly-like stool, sudden evacuation, intestinal gurgling, involuntary stools, diarrhea caused by certain foods or emotional excitement.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0021-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0021-2)</PackageDescription>
<NDC11Code>57955-0021-02</NDC11Code>
<ProductNDC>57955-0021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gout Symptom Relief</ProprietaryName>
<NonProprietaryName>Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0022-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0022-2)</PackageDescription>
<NDC11Code>57955-0022-02</NDC11Code>
<ProductNDC>57955-0022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburn Relief</ProprietaryName>
<NonProprietaryName>Abies Nigra, Arsenicum Album, Condurango, Conium Maculatum, Iris Versicolor, Magnesia Carbonica, Robinia Pseudoacacia, Sulphuricum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptomatic relief of: acid reflux, burning pain, sour stomach, belching, indigestion, nausea, stomach spasms, stomach distention.</IndicationAndUsage>
</NDC>
</NDCList>