{
"NDC": [
{
"NDCCode": "55714-4552-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-4552-2)",
"NDC11Code": "55714-4552-02",
"ProductNDC": "55714-4552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exhaustion Chronic Fatigue",
"NonProprietaryName": "Aconitum Nap., Adrenalinum, Aralia Quinquefolia, Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Cinchona, Iodium, Kali Carb., Kali Iod.,lachesis,lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; EPINEPHRINE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT",
"StrengthNumber": "20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Exhaustion~Chronic Fatigue Formulated for symptoms associated with severe fatigue, Epstein-Barr, Chronic Fatigue Syndrome, adrenal exhaustion and other related conditions."
},
{
"NDCCode": "55714-4552-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-4552-1)",
"NDC11Code": "55714-4552-01",
"ProductNDC": "55714-4552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exhaustion Chronic Fatigue",
"NonProprietaryName": "Aconitum Nap., Adrenalinum, Aralia Quinquefolia, Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Cinchona, Iodium, Kali Carb., Kali Iod.,lachesis,lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; EPINEPHRINE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT",
"StrengthNumber": "20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Exhaustion~Chronic Fatigue Formulated for symptoms associated with severe fatigue, Epstein-Barr, Chronic Fatigue Syndrome, adrenal exhaustion and other related conditions."
},
{
"NDCCode": "0074-4552-72",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0074-4552-72) / 7 TABLET in 1 BLISTER PACK",
"NDC11Code": "00074-4552-72",
"ProductNDC": "0074-4552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Synthroid",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021402",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020724",
"SamplePackage": "Y",
"IndicationAndUsage": "Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:."
},
{
"NDCCode": "66163-4552-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (66163-4552-2) > 60 mL in 1 BOTTLE",
"NDC11Code": "66163-4552-02",
"ProductNDC": "66163-4552",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Josie Maran - Get Even Sun Milk Broad Spectrum Spf 33 Mineral Sunscreen",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Cosmetic Solutions LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "3.15; 4.08",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn: 1 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "66163-4552-4",
"PackageDescription": "2 mL in 1 PACKET (66163-4552-4) ",
"NDC11Code": "66163-4552-04",
"ProductNDC": "66163-4552",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Josie Maran - Get Even Sun Milk Broad Spectrum Spf 33 Mineral Sunscreen",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Cosmetic Solutions LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "3.15; 4.08",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn: 1 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0074-4552-11",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (0074-4552-11) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00074-4552-11",
"ProductNDC": "0074-4552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Synthroid",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021402",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020724",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:."
},
{
"NDCCode": "0074-4552-19",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0074-4552-19) ",
"NDC11Code": "00074-4552-19",
"ProductNDC": "0074-4552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Synthroid",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021402",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020724",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:."
},
{
"NDCCode": "0074-4552-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (0074-4552-90) ",
"NDC11Code": "00074-4552-90",
"ProductNDC": "0074-4552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Synthroid",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021402",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020724",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:."
},
{
"NDCCode": "50090-4552-0",
"PackageDescription": "1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (50090-4552-0) ",
"NDC11Code": "50090-4552-00",
"ProductNDC": "50090-4552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19710303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061395",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190924",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin 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. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for injection, USP is a white to cream-tinged, crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for injection, USP contains ampicillin sodium equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "55714-1101-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1101-2)",
"NDC11Code": "55714-1101-02",
"ProductNDC": "55714-1101",
"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, Ruta, Organic, Cane Dispensing Alcohol",
"DosageFormName": "LIQUID",
"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; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 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",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55714-1102-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1102-2)",
"NDC11Code": "55714-1102-02",
"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": "55714-1103-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1103-2)",
"NDC11Code": "55714-1103-02",
"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": "55714-1104-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1104-2)",
"NDC11Code": "55714-1104-02",
"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": "55714-1105-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1105-2)",
"NDC11Code": "55714-1105-02",
"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": "55714-1106-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1106-2)",
"NDC11Code": "55714-1106-02",
"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": "55714-1107-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1107-2)",
"NDC11Code": "55714-1107-02",
"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": "55714-1108-2",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (55714-1108-2)",
"NDC11Code": "55714-1108-02",
"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": "55714-1110-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1110-2)",
"NDC11Code": "55714-1110-02",
"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": "55714-1112-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1112-2)",
"NDC11Code": "55714-1112-02",
"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": "55714-1113-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1113-2)",
"NDC11Code": "55714-1113-02",
"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": "55714-1114-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1114-2)",
"NDC11Code": "55714-1114-02",
"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": "55714-1115-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1115-2)",
"NDC11Code": "55714-1115-02",
"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": "55714-1116-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1116-2)",
"NDC11Code": "55714-1116-02",
"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": "55714-1118-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-1118-2)",
"NDC11Code": "55714-1118-02",
"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": "55714-1500-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1500-2)",
"NDC11Code": "55714-1500-02",
"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": "55714-1501-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1501-2)",
"NDC11Code": "55714-1501-02",
"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": "55714-1502-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1502-2)",
"NDC11Code": "55714-1502-02",
"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": "55714-1503-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1503-2)",
"NDC11Code": "55714-1503-02",
"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": "55714-1504-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1504-2)",
"NDC11Code": "55714-1504-02",
"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."
},
{
"NDCCode": "55714-1505-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1505-2)",
"NDC11Code": "55714-1505-02",
"ProductNDC": "55714-1505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation",
"NonProprietaryName": "Abies Nig., Aesculus Hipp., Aloe, Alumina, Bryonia, Carbo Veg., Chelidonium Majus, Collinsonia, Graphites, Hydrastis, Kali Carb., Lycopodium, Mag. Mur., Mezereum, Nux Vom., Podoph. Pelt., Rhamnus Purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum Alb., Zinc. Met., Echinacea, Iris Versicolor, Phytolacca, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
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"ProductNdcExcludeFlag": "N",
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}
]
}
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<LastUpdate>2020-01-01</LastUpdate>
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</NDC>
<NDC>
<NDCCode>0074-4552-72</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0074-4552-72) / 7 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-4552-72</NDC11Code>
<ProductNDC>0074-4552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Synthroid</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20020724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021402</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:.</Description>
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<NDC11Code>66163-4552-02</NDC11Code>
<ProductNDC>66163-4552</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Josie Maran - Get Even Sun Milk Broad Spectrum Spf 33 Mineral Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Cosmetic Solutions LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>3.15; 4.08</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn: 1 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
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<NDCCode>66163-4552-4</NDCCode>
<PackageDescription>2 mL in 1 PACKET (66163-4552-4) </PackageDescription>
<NDC11Code>66163-4552-04</NDC11Code>
<ProductNDC>66163-4552</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Josie Maran - Get Even Sun Milk Broad Spectrum Spf 33 Mineral Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Cosmetic Solutions LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>3.15; 4.08</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn: 1 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0074-4552-11</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (0074-4552-11) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-4552-11</NDC11Code>
<ProductNDC>0074-4552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Synthroid</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021402</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:.</Description>
</NDC>
<NDC>
<NDCCode>0074-4552-19</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0074-4552-19) </PackageDescription>
<NDC11Code>00074-4552-19</NDC11Code>
<ProductNDC>0074-4552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Synthroid</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021402</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:.</Description>
</NDC>
<NDC>
<NDCCode>0074-4552-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0074-4552-90) </PackageDescription>
<NDC11Code>00074-4552-90</NDC11Code>
<ProductNDC>0074-4552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Synthroid</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021402</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>SYNTHROID (levothyroxine sodium tablets, USP) is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. SYNTHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each SYNTHROID tablet contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. SYNTHROID tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Each tablet strength meets USP Dissolution Test 3. Table 9 provides a listing of the color additives by tablet strength:.</Description>
</NDC>
<NDC>
<NDCCode>50090-4552-0</NDCCode>
<PackageDescription>1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (50090-4552-0) </PackageDescription>
<NDC11Code>50090-4552-00</NDC11Code>
<ProductNDC>50090-4552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19710303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061395</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions. Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin 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. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for injection, USP is a white to cream-tinged, crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for injection, USP contains ampicillin sodium equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>55714-1101-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1101-2)</PackageDescription>
<NDC11Code>55714-1101-02</NDC11Code>
<ProductNDC>55714-1101</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, Ruta, Organic, Cane Dispensing Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</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; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 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</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1102-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1102-2)</PackageDescription>
<NDC11Code>55714-1102-02</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>55714-1103-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1103-2)</PackageDescription>
<NDC11Code>55714-1103-02</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>55714-1104-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1104-2)</PackageDescription>
<NDC11Code>55714-1104-02</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>55714-1105-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1105-2)</PackageDescription>
<NDC11Code>55714-1105-02</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>55714-1106-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1106-2)</PackageDescription>
<NDC11Code>55714-1106-02</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>55714-1107-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1107-2)</PackageDescription>
<NDC11Code>55714-1107-02</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>55714-1108-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (55714-1108-2)</PackageDescription>
<NDC11Code>55714-1108-02</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>55714-1110-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1110-2)</PackageDescription>
<NDC11Code>55714-1110-02</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>55714-1112-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1112-2)</PackageDescription>
<NDC11Code>55714-1112-02</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>55714-1113-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1113-2)</PackageDescription>
<NDC11Code>55714-1113-02</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>55714-1114-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1114-2)</PackageDescription>
<NDC11Code>55714-1114-02</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>55714-1115-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1115-2)</PackageDescription>
<NDC11Code>55714-1115-02</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>55714-1116-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1116-2)</PackageDescription>
<NDC11Code>55714-1116-02</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>55714-1118-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-1118-2)</PackageDescription>
<NDC11Code>55714-1118-02</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>55714-1500-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1500-2)</PackageDescription>
<NDC11Code>55714-1500-02</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>55714-1501-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1501-2)</PackageDescription>
<NDC11Code>55714-1501-02</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>55714-1502-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1502-2)</PackageDescription>
<NDC11Code>55714-1502-02</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>55714-1503-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1503-2)</PackageDescription>
<NDC11Code>55714-1503-02</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>55714-1504-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1504-2)</PackageDescription>
<NDC11Code>55714-1504-02</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>
<NDC>
<NDCCode>55714-1505-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1505-2)</PackageDescription>
<NDC11Code>55714-1505-02</NDC11Code>
<ProductNDC>55714-1505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation</ProprietaryName>
<NonProprietaryName>Abies Nig., Aesculus Hipp., Aloe, Alumina, Bryonia, Carbo Veg., Chelidonium Majus, Collinsonia, Graphites, Hydrastis, Kali Carb., Lycopodium, Mag. Mur., Mezereum, Nux Vom., Podoph. Pelt., Rhamnus Purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum Alb., Zinc. Met., Echinacea, Iris Versicolor, Phytolacca, Taraxacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; HORSE CHESTNUT; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; FRANGULA PURSHIANA BARK; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE</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; 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; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Constipation Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.</IndicationAndUsage>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>55714-4552-2</NDCCode><ProprietaryName>Exhaustion Chronic Fatigue</ProprietaryName><NonProprietaryName>Aconitum Nap., Adrenalinum, Aralia Quinquefolia, Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Cinchona, Iodium, Kali Carb., Kali Iod.,lachesis,lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55714-4552-1</NDCCode><ProprietaryName>Exhaustion Chronic Fatigue</ProprietaryName><NonProprietaryName>Aconitum Nap., Adrenalinum, Aralia Quinquefolia, Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Cinchona, Iodium, Kali Carb., Kali Iod.,lachesis,lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, Alcohol</NonProprietaryName></NDC><NDC><NDCCode>0074-4552-72</NDCCode><ProprietaryName>Synthroid</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>66163-4552-2</NDCCode><ProprietaryName>Josie Maran - Get Even Sun Milk Broad Spectrum Spf 33 Mineral Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>66163-4552-4</NDCCode><ProprietaryName>Josie Maran - Get Even Sun Milk Broad Spectrum Spf 33 Mineral Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>0074-4552-11</NDCCode><ProprietaryName>Synthroid</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>0074-4552-19</NDCCode><ProprietaryName>Synthroid</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>0074-4552-90</NDCCode><ProprietaryName>Synthroid</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>50090-4552-0</NDCCode><ProprietaryName>Ampicillin</ProprietaryName><NonProprietaryName>Ampicillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>55714-1101-2</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, Ruta, Organic, Cane Dispensing Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55714-1102-2</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>55714-1103-2</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>55714-1104-2</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>55714-1105-2</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>55714-1106-2</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>55714-1107-2</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>55714-1108-2</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>55714-1110-2</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>55714-1112-2</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>55714-1113-2</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>55714-1114-2</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>55714-1115-2</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>55714-1116-2</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>55714-1118-2</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>55714-1500-2</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>55714-1501-2</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>55714-1502-2</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>55714-1503-2</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>55714-1504-2</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><NDC><NDCCode>55714-1505-2</NDCCode><ProprietaryName>Constipation</ProprietaryName><NonProprietaryName>Abies Nig., Aesculus Hipp., Aloe, Alumina, Bryonia, Carbo Veg., Chelidonium Majus, Collinsonia, Graphites, Hydrastis, Kali Carb., Lycopodium, Mag. Mur., Mezereum, Nux Vom., Podoph. Pelt., Rhamnus Purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum Alb., Zinc. Met., Echinacea, Iris Versicolor, Phytolacca, Taraxacum</NonProprietaryName></NDC></NDCList>