{
"NDC": [
{
"NDCCode": "55714-2238-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-2238-0)",
"NDC11Code": "55714-2238-00",
"ProductNDC": "55714-2238",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indigestion - Gas",
"NonProprietaryName": "Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indigestion - Gas Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence."
},
{
"NDCCode": "50090-2238-0",
"PackageDescription": "25 VIAL in 1 CARTON (50090-2238-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "50090-2238-00",
"ProductNDC": "50090-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefazolin",
"NonProprietaryName": "Cefazolin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20150306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065303",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEFAZOLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20151120",
"SamplePackage": "N",
"IndicationAndUsage": "Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin‑sensitive and penicillin-resistant), group A beta‑hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella species, and S. aureus. Bone and Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci. Septicemia: Due to S. pneumoniae, S. aureus (penicillin‑sensitive and penicillin‑resistant), P. mirabilis, E. coli, and Klebsiella species. Endocarditis: Due to S. aureus (penicillin‑sensitive and penicillin‑resistant) and group A beta‑hemolytic streptococci. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high‑risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open‑heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection should usually be discontinued within a 24‑hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.). To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. Structural Formula. C14H13N8NaO4S3 M.W. 476.5. The pH of the reconstituted solution is between 4 and 6. Cefazolin for Injection, USP is a sterile white to cream powder supplied in vials. Each vial contains, cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin. The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin sodium or approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. Cefazolin for Injection, USP is to be administered by intramuscular or intravenous routes."
},
{
"NDCCode": "70518-2238-0",
"PackageDescription": "30 POUCH in 1 BOX (70518-2238-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2238-1) ",
"NDC11Code": "70518-2238-00",
"ProductNDC": "70518-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090681",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190730",
"SamplePackage": "N"
},
{
"NDCCode": "55714-2238-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-2238-1)",
"NDC11Code": "55714-2238-01",
"ProductNDC": "55714-2238",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indigestion - Gas",
"NonProprietaryName": "Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indigestion - Gas Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence."
},
{
"NDCCode": "55714-2238-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-2238-2)",
"NDC11Code": "55714-2238-02",
"ProductNDC": "55714-2238",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indigestion - Gas",
"NonProprietaryName": "Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indigestion - Gas Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence."
},
{
"NDCCode": "36987-2238-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2238-1)",
"NDC11Code": "36987-2238-01",
"ProductNDC": "36987-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobacco Leaf",
"NonProprietaryName": "Tobacco Leaf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "TOBACCO LEAF",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2238-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2238-2)",
"NDC11Code": "36987-2238-02",
"ProductNDC": "36987-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobacco Leaf",
"NonProprietaryName": "Tobacco Leaf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "TOBACCO LEAF",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2238-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2238-3)",
"NDC11Code": "36987-2238-03",
"ProductNDC": "36987-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobacco Leaf",
"NonProprietaryName": "Tobacco Leaf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "TOBACCO LEAF",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2238-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-2238-4)",
"NDC11Code": "36987-2238-04",
"ProductNDC": "36987-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobacco Leaf",
"NonProprietaryName": "Tobacco Leaf",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "TOBACCO LEAF",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "67296-2238-2",
"PackageDescription": "5 TABLET in 1 BOTTLE, PLASTIC (67296-2238-2) ",
"NDC11Code": "67296-2238-02",
"ProductNDC": "67296-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072927",
"LabelerName": "Redpharm Drug",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211209",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "67296-2238-4",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (67296-2238-4) ",
"NDC11Code": "67296-2238-04",
"ProductNDC": "67296-2238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072927",
"LabelerName": "Redpharm Drug",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220111",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "55714-1102-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1102-0)",
"NDC11Code": "55714-1102-00",
"ProductNDC": "55714-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sick Stopper",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms."
},
{
"NDCCode": "55714-1103-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1103-0)",
"NDC11Code": "55714-1103-00",
"ProductNDC": "55714-1103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swimmers Support",
"NonProprietaryName": "Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness."
},
{
"NDCCode": "55714-1104-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1104-0)",
"NDC11Code": "55714-1104-00",
"ProductNDC": "55714-1104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hangover Help",
"NonProprietaryName": "Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache."
},
{
"NDCCode": "55714-1105-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1105-0)",
"NDC11Code": "55714-1105-00",
"ProductNDC": "55714-1105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Plus",
"NonProprietaryName": "Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin."
},
{
"NDCCode": "55714-1106-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1106-0)",
"NDC11Code": "55714-1106-00",
"ProductNDC": "55714-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panic Button",
"NonProprietaryName": "Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-1107-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1107-0)",
"NDC11Code": "55714-1107-00",
"ProductNDC": "55714-1107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sports Injury",
"NonProprietaryName": "Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "55714-1108-0",
"PackageDescription": "15 mL in 1 BOTTLE, GLASS (55714-1108-0)",
"NDC11Code": "55714-1108-00",
"ProductNDC": "55714-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sports Recovery",
"NonProprietaryName": "Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160725",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sports Recovery Formulated for workout recovery and for symptoms associated with injury, overexertion and emotional distress."
},
{
"NDCCode": "55714-1110-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1110-0)",
"NDC11Code": "55714-1110-00",
"ProductNDC": "55714-1110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jet Lag",
"NonProprietaryName": "Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort."
},
{
"NDCCode": "55714-1112-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1112-0)",
"NDC11Code": "55714-1112-00",
"ProductNDC": "55714-1112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swimmers Support",
"NonProprietaryName": "Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness."
},
{
"NDCCode": "55714-1113-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1113-0)",
"NDC11Code": "55714-1113-00",
"ProductNDC": "55714-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hangover Help",
"NonProprietaryName": "Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache."
},
{
"NDCCode": "55714-1114-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1114-0)",
"NDC11Code": "55714-1114-00",
"ProductNDC": "55714-1114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sick Stopper",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms."
},
{
"NDCCode": "55714-1115-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1115-0)",
"NDC11Code": "55714-1115-00",
"ProductNDC": "55714-1115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panic Button",
"NonProprietaryName": "Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-1116-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1116-0)",
"NDC11Code": "55714-1116-00",
"ProductNDC": "55714-1116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sports Injury",
"NonProprietaryName": "Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "55714-1118-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1118-0)",
"NDC11Code": "55714-1118-00",
"ProductNDC": "55714-1118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jet Lag",
"NonProprietaryName": "Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort."
},
{
"NDCCode": "55714-1500-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1500-0)",
"NDC11Code": "55714-1500-00",
"ProductNDC": "55714-1500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Detoxifier",
"NonProprietaryName": "Uricum Acidum, Benzoicum Acidum, Berber. Vulg., Bryonia, Cantharis, Carduus Benedictus, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Dioscorea, Dolichos, Iris Versicolor, Juniperus Com., Nux Vom., Ptelea, Taraxacum, Carduus Mar., Cynara Scolymus, Solidago",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Detoxifier Formulated for liver and kidney functions and for symptoms associated with toxicity such as newborn jaundice, hypersensitivity and sluggish elimination."
},
{
"NDCCode": "55714-1501-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1501-0)",
"NDC11Code": "55714-1501-00",
"ProductNDC": "55714-1501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Asthma Rescue - Cough",
"NonProprietaryName": "Influenzinum, Antimon. Tart., Arsenicum Alb., Bryonia, Chelidonium Majus, Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb., Kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phosphorus, Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Farfara, Verbascum, Echinacea, Lappa.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; INFLUENZA B VIRUS",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "55714-1502-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1502-0)",
"NDC11Code": "55714-1502-00",
"ProductNDC": "55714-1502",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sniffles",
"NonProprietaryName": "Influenzinum, Aconitum Nap., Aralia Quinquefolia, Arsenicum Alb., Bryonia, Euphrasia, Gaultheria Procumbens, Gelsemium, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Lycopodium, Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salvia, Sticta, Thuja Occ., Verbascum, Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "INFLUENZA A VIRUS; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sniffles Formulated for symptoms such as congestion, runny nose, post-nasal drip, sinus pressure and irritated throat."
},
{
"NDCCode": "55714-1503-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1503-0)",
"NDC11Code": "55714-1503-00",
"ProductNDC": "55714-1503",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fever Infection",
"NonProprietaryName": "Influenzinum, Aconitum Nap., Arsenicum Alb., Belladonna, Bryonia, Camphora, Cina, Cinchona, Eupatorium Perf., Ferrum Phosphoricum, Gelsemium, Hepar Sulph. Calc., Ignatia, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Salix Nigra,veratrum Viride, Chamomilla, Echinacea, Hydrastis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "INFLUENZA A VIRUS; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; VERATRUM VIRIDE ROOT; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; FERROSOFERRIC PHOSPHATE; INFLUENZA B VIRUS",
"StrengthNumber": "30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 15; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Fever - Infection Formulated for associated symptoms such as chills, aches, sweating, fatigue, nausea and loss of appetite."
},
{
"NDCCode": "55714-1504-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1504-0)",
"NDC11Code": "55714-1504-00",
"ProductNDC": "55714-1504",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ear Care",
"NonProprietaryName": "Influenzinum, Tellurium Metallicum, Apis Mel., Arsenicum Alb., Belladonna, Bryonia, Capsicum, Austicum, Cinchona, Conium,dulcamara, Ferrum Phosphoricum, Hepar Sulph. Calc.,kali Sulph., Ycopodium, Merc. Viv., Mezereum,phosphorus, Plantago, Pulsatilla, Silicea,verbascum, Echinacea, Hydrastis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS",
"StrengthNumber": "30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ear Care Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability."
}
]
}
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<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-2238-0)</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum</NonProprietaryName>
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<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
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<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<PackageDescription>25 VIAL in 1 CARTON (50090-2238-0) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>50090-2238-00</NDC11Code>
<ProductNDC>50090-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefazolin</ProprietaryName>
<NonProprietaryName>Cefazolin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20150306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065303</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CEFAZOLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefazolin for Injection, USP is indicated for the treatment of the following serious infections when due to susceptible organisms. Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin‑sensitive and penicillin-resistant), group A beta‑hemolytic streptococci, and other strains of streptococci. Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella species, and S. aureus. Bone and Joint Infections: Due to S. aureus. Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterococci. Septicemia: Due to S. pneumoniae, S. aureus (penicillin‑sensitive and penicillin‑resistant), P. mirabilis, E. coli, and Klebsiella species. Endocarditis: Due to S. aureus (penicillin‑sensitive and penicillin‑resistant) and group A beta‑hemolytic streptococci. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high‑risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). The perioperative use of Cefazolin for Injection may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open‑heart surgery and prosthetic arthroplasty). The prophylactic administration of Cefazolin for Injection should usually be discontinued within a 24‑hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.). To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. Structural Formula. C14H13N8NaO4S3 M.W. 476.5. The pH of the reconstituted solution is between 4 and 6. Cefazolin for Injection, USP is a sterile white to cream powder supplied in vials. Each vial contains, cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin. The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin sodium or approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. Cefazolin for Injection, USP is to be administered by intramuscular or intravenous routes.</Description>
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<NDC11Code>70518-2238-00</NDC11Code>
<ProductNDC>70518-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
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<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090681</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-2238-1)</PackageDescription>
<NDC11Code>55714-2238-01</NDC11Code>
<ProductNDC>55714-2238</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Indigestion - Gas</ProprietaryName>
<NonProprietaryName>Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indigestion - Gas Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence.</IndicationAndUsage>
</NDC>
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<NDCCode>55714-2238-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-2238-2)</PackageDescription>
<NDC11Code>55714-2238-02</NDC11Code>
<ProductNDC>55714-2238</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Indigestion - Gas</ProprietaryName>
<NonProprietaryName>Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indigestion - Gas Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-2238-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2238-1)</PackageDescription>
<NDC11Code>36987-2238-01</NDC11Code>
<ProductNDC>36987-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobacco Leaf</ProprietaryName>
<NonProprietaryName>Tobacco Leaf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>TOBACCO LEAF</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2238-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2238-2)</PackageDescription>
<NDC11Code>36987-2238-02</NDC11Code>
<ProductNDC>36987-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobacco Leaf</ProprietaryName>
<NonProprietaryName>Tobacco Leaf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>TOBACCO LEAF</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2238-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2238-3)</PackageDescription>
<NDC11Code>36987-2238-03</NDC11Code>
<ProductNDC>36987-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobacco Leaf</ProprietaryName>
<NonProprietaryName>Tobacco Leaf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>TOBACCO LEAF</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2238-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-2238-4)</PackageDescription>
<NDC11Code>36987-2238-04</NDC11Code>
<ProductNDC>36987-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobacco Leaf</ProprietaryName>
<NonProprietaryName>Tobacco Leaf</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>TOBACCO LEAF</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>67296-2238-2</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE, PLASTIC (67296-2238-2) </PackageDescription>
<NDC11Code>67296-2238-02</NDC11Code>
<ProductNDC>67296-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072927</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>67296-2238-4</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (67296-2238-4) </PackageDescription>
<NDC11Code>67296-2238-04</NDC11Code>
<ProductNDC>67296-2238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072927</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>55714-1102-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1102-0)</PackageDescription>
<NDC11Code>55714-1102-00</NDC11Code>
<ProductNDC>55714-1102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sick Stopper</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1103-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1103-0)</PackageDescription>
<NDC11Code>55714-1103-00</NDC11Code>
<ProductNDC>55714-1103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swimmers Support</ProprietaryName>
<NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1104-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1104-0)</PackageDescription>
<NDC11Code>55714-1104-00</NDC11Code>
<ProductNDC>55714-1104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hangover Help</ProprietaryName>
<NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1105-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1105-0)</PackageDescription>
<NDC11Code>55714-1105-00</NDC11Code>
<ProductNDC>55714-1105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prime Plus</ProprietaryName>
<NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1106-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1106-0)</PackageDescription>
<NDC11Code>55714-1106-00</NDC11Code>
<ProductNDC>55714-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panic Button</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1107-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1107-0)</PackageDescription>
<NDC11Code>55714-1107-00</NDC11Code>
<ProductNDC>55714-1107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sports Injury</ProprietaryName>
<NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>55714-1108-0</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, GLASS (55714-1108-0)</PackageDescription>
<NDC11Code>55714-1108-00</NDC11Code>
<ProductNDC>55714-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sports Recovery</ProprietaryName>
<NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160725</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sports Recovery Formulated for workout recovery and for symptoms associated with injury, overexertion and emotional distress.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1110-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1110-0)</PackageDescription>
<NDC11Code>55714-1110-00</NDC11Code>
<ProductNDC>55714-1110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jet Lag</ProprietaryName>
<NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1112-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1112-0)</PackageDescription>
<NDC11Code>55714-1112-00</NDC11Code>
<ProductNDC>55714-1112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swimmers Support</ProprietaryName>
<NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1113-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1113-0)</PackageDescription>
<NDC11Code>55714-1113-00</NDC11Code>
<ProductNDC>55714-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hangover Help</ProprietaryName>
<NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1114-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1114-0)</PackageDescription>
<NDC11Code>55714-1114-00</NDC11Code>
<ProductNDC>55714-1114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sick Stopper</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1115-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1115-0)</PackageDescription>
<NDC11Code>55714-1115-00</NDC11Code>
<ProductNDC>55714-1115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panic Button</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1116-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1116-0)</PackageDescription>
<NDC11Code>55714-1116-00</NDC11Code>
<ProductNDC>55714-1116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sports Injury</ProprietaryName>
<NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>55714-1118-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1118-0)</PackageDescription>
<NDC11Code>55714-1118-00</NDC11Code>
<ProductNDC>55714-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jet Lag</ProprietaryName>
<NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1500-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1500-0)</PackageDescription>
<NDC11Code>55714-1500-00</NDC11Code>
<ProductNDC>55714-1500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Detoxifier</ProprietaryName>
<NonProprietaryName>Uricum Acidum, Benzoicum Acidum, Berber. Vulg., Bryonia, Cantharis, Carduus Benedictus, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Dioscorea, Dolichos, Iris Versicolor, Juniperus Com., Nux Vom., Ptelea, Taraxacum, Carduus Mar., Cynara Scolymus, Solidago</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Detoxifier Formulated for liver and kidney functions and for symptoms associated with toxicity such as newborn jaundice, hypersensitivity and sluggish elimination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1501-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1501-0)</PackageDescription>
<NDC11Code>55714-1501-00</NDC11Code>
<ProductNDC>55714-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Asthma Rescue - Cough</ProprietaryName>
<NonProprietaryName>Influenzinum, Antimon. Tart., Arsenicum Alb., Bryonia, Chelidonium Majus, Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb., Kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phosphorus, Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Farfara, Verbascum, Echinacea, Lappa.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>55714-1502-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1502-0)</PackageDescription>
<NDC11Code>55714-1502-00</NDC11Code>
<ProductNDC>55714-1502</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sniffles</ProprietaryName>
<NonProprietaryName>Influenzinum, Aconitum Nap., Aralia Quinquefolia, Arsenicum Alb., Bryonia, Euphrasia, Gaultheria Procumbens, Gelsemium, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Lycopodium, Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salvia, Sticta, Thuja Occ., Verbascum, Echinacea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sniffles Formulated for symptoms such as congestion, runny nose, post-nasal drip, sinus pressure and irritated throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1503-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1503-0)</PackageDescription>
<NDC11Code>55714-1503-00</NDC11Code>
<ProductNDC>55714-1503</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fever Infection</ProprietaryName>
<NonProprietaryName>Influenzinum, Aconitum Nap., Arsenicum Alb., Belladonna, Bryonia, Camphora, Cina, Cinchona, Eupatorium Perf., Ferrum Phosphoricum, Gelsemium, Hepar Sulph. Calc., Ignatia, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Salix Nigra,veratrum Viride, Chamomilla, Echinacea, Hydrastis.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; VERATRUM VIRIDE ROOT; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; FERROSOFERRIC PHOSPHATE; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 15; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fever - Infection Formulated for associated symptoms such as chills, aches, sweating, fatigue, nausea and loss of appetite.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1504-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1504-0)</PackageDescription>
<NDC11Code>55714-1504-00</NDC11Code>
<ProductNDC>55714-1504</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ear Care</ProprietaryName>
<NonProprietaryName>Influenzinum, Tellurium Metallicum, Apis Mel., Arsenicum Alb., Belladonna, Bryonia, Capsicum, Austicum, Cinchona, Conium,dulcamara, Ferrum Phosphoricum, Hepar Sulph. Calc.,kali Sulph., Ycopodium, Merc. Viv., Mezereum,phosphorus, Plantago, Pulsatilla, Silicea,verbascum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ear Care Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.</IndicationAndUsage>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>55714-2238-0</NDCCode><ProprietaryName>Indigestion - Gas</ProprietaryName><NonProprietaryName>Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum</NonProprietaryName></NDC><NDC><NDCCode>50090-2238-0</NDCCode><ProprietaryName>Cefazolin</ProprietaryName><NonProprietaryName>Cefazolin</NonProprietaryName></NDC><NDC><NDCCode>70518-2238-0</NDCCode><ProprietaryName>Quetiapine Fumarate</ProprietaryName><NonProprietaryName>Quetiapine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>55714-2238-1</NDCCode><ProprietaryName>Indigestion - Gas</ProprietaryName><NonProprietaryName>Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum</NonProprietaryName></NDC><NDC><NDCCode>55714-2238-2</NDCCode><ProprietaryName>Indigestion - Gas</ProprietaryName><NonProprietaryName>Bismuthum Metallicum, Aloe, Angelica Sinensis Radix, Antimon. Crud., Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. Carb., Nux Vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris Versicolor, Ruta, Taraxacum</NonProprietaryName></NDC><NDC><NDCCode>36987-2238-1</NDCCode><ProprietaryName>Tobacco Leaf</ProprietaryName><NonProprietaryName>Tobacco Leaf</NonProprietaryName></NDC><NDC><NDCCode>36987-2238-2</NDCCode><ProprietaryName>Tobacco Leaf</ProprietaryName><NonProprietaryName>Tobacco Leaf</NonProprietaryName></NDC><NDC><NDCCode>36987-2238-3</NDCCode><ProprietaryName>Tobacco Leaf</ProprietaryName><NonProprietaryName>Tobacco Leaf</NonProprietaryName></NDC><NDC><NDCCode>36987-2238-4</NDCCode><ProprietaryName>Tobacco Leaf</ProprietaryName><NonProprietaryName>Tobacco Leaf</NonProprietaryName></NDC><NDC><NDCCode>67296-2238-2</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>67296-2238-4</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>55714-1102-0</NDCCode><ProprietaryName>Sick Stopper</ProprietaryName><NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1103-0</NDCCode><ProprietaryName>Swimmers Support</ProprietaryName><NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName></NDC><NDC><NDCCode>55714-1104-0</NDCCode><ProprietaryName>Hangover Help</ProprietaryName><NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1105-0</NDCCode><ProprietaryName>Prime Plus</ProprietaryName><NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName></NDC><NDC><NDCCode>55714-1106-0</NDCCode><ProprietaryName>Panic Button</ProprietaryName><NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName></NDC><NDC><NDCCode>55714-1107-0</NDCCode><ProprietaryName>Sports Injury</ProprietaryName><NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName></NDC><NDC><NDCCode>55714-1108-0</NDCCode><ProprietaryName>Sports Recovery</ProprietaryName><NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName></NDC><NDC><NDCCode>55714-1110-0</NDCCode><ProprietaryName>Jet Lag</ProprietaryName><NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1112-0</NDCCode><ProprietaryName>Swimmers Support</ProprietaryName><NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName></NDC><NDC><NDCCode>55714-1113-0</NDCCode><ProprietaryName>Hangover Help</ProprietaryName><NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1114-0</NDCCode><ProprietaryName>Sick Stopper</ProprietaryName><NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1115-0</NDCCode><ProprietaryName>Panic Button</ProprietaryName><NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1116-0</NDCCode><ProprietaryName>Sports Injury</ProprietaryName><NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName></NDC><NDC><NDCCode>55714-1118-0</NDCCode><ProprietaryName>Jet Lag</ProprietaryName><NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1500-0</NDCCode><ProprietaryName>Detoxifier</ProprietaryName><NonProprietaryName>Uricum Acidum, Benzoicum Acidum, Berber. Vulg., Bryonia, Cantharis, Carduus Benedictus, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Dioscorea, Dolichos, Iris Versicolor, Juniperus Com., Nux Vom., Ptelea, Taraxacum, Carduus Mar., Cynara Scolymus, Solidago</NonProprietaryName></NDC><NDC><NDCCode>55714-1501-0</NDCCode><ProprietaryName>Asthma Rescue - Cough</ProprietaryName><NonProprietaryName>Influenzinum, Antimon. Tart., Arsenicum Alb., Bryonia, Chelidonium Majus, Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb., Kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phosphorus, Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Farfara, Verbascum, Echinacea, Lappa.</NonProprietaryName></NDC><NDC><NDCCode>55714-1502-0</NDCCode><ProprietaryName>Sniffles</ProprietaryName><NonProprietaryName>Influenzinum, Aconitum Nap., Aralia Quinquefolia, Arsenicum Alb., Bryonia, Euphrasia, Gaultheria Procumbens, Gelsemium, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Lycopodium, Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salvia, Sticta, Thuja Occ., Verbascum, Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1503-0</NDCCode><ProprietaryName>Fever Infection</ProprietaryName><NonProprietaryName>Influenzinum, Aconitum Nap., Arsenicum Alb., Belladonna, Bryonia, Camphora, Cina, Cinchona, Eupatorium Perf., Ferrum Phosphoricum, Gelsemium, Hepar Sulph. Calc., Ignatia, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Salix Nigra,veratrum Viride, Chamomilla, Echinacea, Hydrastis.</NonProprietaryName></NDC><NDC><NDCCode>55714-1504-0</NDCCode><ProprietaryName>Ear Care</ProprietaryName><NonProprietaryName>Influenzinum, Tellurium Metallicum, Apis Mel., Arsenicum Alb., Belladonna, Bryonia, Capsicum, Austicum, Cinchona, Conium,dulcamara, Ferrum Phosphoricum, Hepar Sulph. Calc.,kali Sulph., Ycopodium, Merc. Viv., Mezereum,phosphorus, Plantago, Pulsatilla, Silicea,verbascum, Echinacea, Hydrastis</NonProprietaryName></NDC></NDCList>