RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>63083-9635-1</NDCCode>
    <PackageDescription>29.5 mL in 1 BOTTLE, DROPPER (63083-9635-1) </PackageDescription>
    <NDC11Code>63083-9635-01</NDC11Code>
    <ProductNDC>63083-9635</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Brachial Drops</ProprietaryName>
    <ProprietaryNameSuffix>9635</ProprietaryNameSuffix>
    <NonProprietaryName>Brachial Drops</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>BOS TAURUS ARTERY</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>[hp_X]/29.5mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>22840-9635-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-9635-2) </PackageDescription>
    <NDC11Code>22840-9635-02</NDC11Code>
    <ProductNDC>22840-9635</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Dematiaceae Mix</ProprietaryName>
    <NonProprietaryName>Alternaria Alternata, Aureobasidium Pullulans, Bipolaris Sorokiniana, Cladosporium Herbarum, Curvularia Spicifera And Helminthosporium Solani</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>COCHLIOBOLUS SPICIFER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; COCHLIOBOLUS SATIVUS; ALTERNARIA ALTERNATA; CLADOSPORIUM HERBARUM; HELMINTHOSPORIUM SOLANI</SubstanceName>
    <StrengthNumber>.0042; .0042; .0042; .0042; .0042; .0042</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>22840-9635-5</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE, DROPPER (22840-9635-5) </PackageDescription>
    <NDC11Code>22840-9635-05</NDC11Code>
    <ProductNDC>22840-9635</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Dematiaceae Mix</ProprietaryName>
    <NonProprietaryName>Alternaria Alternata, Aureobasidium Pullulans, Bipolaris Sorokiniana, Cladosporium Herbarum, Curvularia Spicifera And Helminthosporium Solani</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>COCHLIOBOLUS SPICIFER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; COCHLIOBOLUS SATIVUS; ALTERNARIA ALTERNATA; CLADOSPORIUM HERBARUM; HELMINTHOSPORIUM SOLANI</SubstanceName>
    <StrengthNumber>.0042; .0042; .0042; .0042; .0042; .0042</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19810915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
    <Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
  </NDC>
  <NDC>
    <NDCCode>63629-9635-1</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9635-1) </PackageDescription>
    <NDC11Code>63629-9635-01</NDC11Code>
    <ProductNDC>63629-9635</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090132</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2) , 3 hypertension ( 1.3) .</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha 1-blocking activity. It is (2 RS)-1-(9 H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure:. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C 24H 26N 2O 4H 3PO 41/2 H 2O. Carvedilol phosphate extended-release capsules are available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate controlled-release minitablets that are coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate, methacrylic acid methyl methacrylate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, talc and triethyl citrate. The capsule shell contains gelatin and titanium dioxide. The 20 mg capsule shell also contains FD&amp;C blue #1, FD&amp;C yellow #5 and FD&amp;C yellow #6. The 40 mg capsule shell also contains D&amp;C yellow #10 and FD&amp;C yellow #6. The 80 mg capsule shell also contains D&amp;C yellow #10 and FD&amp;C blue #1. The imprinting ink for the 10 mg, 40 mg and 80 mg contains D&amp;C yellow #10 lake, FD&amp;C blue #1, FD&amp;C blue #2, FD&amp;C red #40, iron oxide black, propylene glycol and shellac glaze. The imprinting ink for the 20 mg contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63629-9635-2</NDCCode>
    <PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9635-2) </PackageDescription>
    <NDC11Code>63629-9635-02</NDC11Code>
    <ProductNDC>63629-9635</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carvedilol Phosphate</ProprietaryName>
    <NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090132</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230511</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2) , 3 hypertension ( 1.3) .</IndicationAndUsage>
    <Description>Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha 1-blocking activity. It is (2 RS)-1-(9 H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure:. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C 24H 26N 2O 4H 3PO 41/2 H 2O. Carvedilol phosphate extended-release capsules are available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate controlled-release minitablets that are coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate, methacrylic acid methyl methacrylate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, talc and triethyl citrate. The capsule shell contains gelatin and titanium dioxide. The 20 mg capsule shell also contains FD&amp;C blue #1, FD&amp;C yellow #5 and FD&amp;C yellow #6. The 40 mg capsule shell also contains D&amp;C yellow #10 and FD&amp;C yellow #6. The 80 mg capsule shell also contains D&amp;C yellow #10 and FD&amp;C blue #1. The imprinting ink for the 10 mg, 40 mg and 80 mg contains D&amp;C yellow #10 lake, FD&amp;C blue #1, FD&amp;C blue #2, FD&amp;C red #40, iron oxide black, propylene glycol and shellac glaze. The imprinting ink for the 20 mg contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-9635-1</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (71335-9635-1) </PackageDescription>
    <NDC11Code>71335-9635-01</NDC11Code>
    <ProductNDC>71335-9635</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210526</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214548</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a, d] cycloheptene-Δ5 , γ-propylamine hydrochloride. It has the following structural formula. C20H23N.HCl.  M.W.   313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included:. 10 mg-D&amp;C Red #27 Phloxine Aluminum Lake, D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;.  50 mg-D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake and FD&amp;C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&amp;C Yellow #10 Aluminum Lake and D&amp;C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Blue #1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-9635-2</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71335-9635-2) </PackageDescription>
    <NDC11Code>71335-9635-02</NDC11Code>
    <ProductNDC>71335-9635</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210526</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214548</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a, d] cycloheptene-Δ5 , γ-propylamine hydrochloride. It has the following structural formula. C20H23N.HCl.  M.W.   313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included:. 10 mg-D&amp;C Red #27 Phloxine Aluminum Lake, D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;.  50 mg-D&amp;C Yellow #10 Aluminum Lake, FD&amp;C Red #40 Aluminum Lake and FD&amp;C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&amp;C Yellow #10 Aluminum Lake and D&amp;C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&amp;C Yellow #10 Aluminum Lake and FD&amp;C Blue #1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-9635-3</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71335-9635-3) </PackageDescription>
    <NDC11Code>71335-9635-03</NDC11Code>
    <ProductNDC>71335-9635</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210526</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214548</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
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    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; BLUE TILAPIA WHOLE; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED; COW MILK FAT; CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED; WHEY; SWISS CHARD; COW MILK; GOAT MILK; HUMAN MILK</SubstanceName>
    <StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Milk Proteins [CS], Milk Proteins [CS], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63083-1008-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1008-2) </PackageDescription>
    <NDC11Code>63083-1008-02</NDC11Code>
    <ProductNDC>63083-1008</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Flowers</ProprietaryName>
    <ProprietaryNameSuffix>1008</ProprietaryNameSuffix>
    <NonProprietaryName>Flowers</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; SYMPHYOTRICHUM OBLONGIFOLIUM WHOLE; CAMELLIA CHEKIANGOLEOSA SEED OIL; DIANTHUS CARYOPHYLLUS WHOLE; KALIMERIS INDICA WHOLE; NARCISSUS POETICUS WHOLE; TOWNSENDIA EXSCAPA WHOLE; GARDENIA JASMINOIDES FRUIT; GENTIANA LUTEA ROOT; GLADIOLUS COMMUNIS WHOLE; LONICERA CANADENSIS WHOLE; C12-17 ALKANE; DELPHINIUM AJACIS SEED; DIANTHUS SUPERBUS FLOWERING TOP; HEDYCHIUM FLAVESCENS WHOLE; LUPINUS ELEGANS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; NERIUM OLEANDER WHOLE; VIOLA TRICOLOR WHOLE; PAEONIA X SUFFRUTICOSA SEED; RUELLIA SIMPLEX WHOLE; ESCHSCHOLZIA CALIFORNICA FLOWERING TOP; SEDUM ROSEUM WHOLE; ANTIRRHINUM MAJUS LEAF; LIRIODENDRON TULIPIFERA WHOLE</SubstanceName>
    <StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63083-1011-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1011-2) </PackageDescription>
    <NDC11Code>63083-1011-02</NDC11Code>
    <ProductNDC>63083-1011</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nightshade Mix</ProprietaryName>
    <ProprietaryNameSuffix>1011</ProprietaryNameSuffix>
    <NonProprietaryName>Nightshade Mix</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; CAPSICUM; EGGPLANT; PHYSALIS VIRGINIANA WHOLE; CULTIVATED MUSHROOM; MUSTARD GREENS; PEPPERS; POTATO; TOBACCO LEAF; TOMATO</SubstanceName>
    <StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63083-1012-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1012-2) </PackageDescription>
    <NDC11Code>63083-1012-02</NDC11Code>
    <ProductNDC>63083-1012</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nut Mix</ProprietaryName>
    <ProprietaryNameSuffix>1012</ProprietaryNameSuffix>
    <NonProprietaryName>Nut Mix</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ALMOND; BLACK WALNUT; BRAZIL NUT; CASHEW; COCONUT; ENGLISH WALNUT; HAZELNUT, UNSPECIFIED; CARYA LACINIOSA BARK; GREEN OLIVE; PEANUT; PECAN; PINUS CEMBROIDES POLLEN; PISTACHIO; SPANISH CHESTNUT</SubstanceName>
    <StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Nut Proteins [EXT], Nut Proteins [EXT], Nut Proteins [EXT], Nut Proteins [EXT], Nut Proteins [EXT], Nut Proteins [EXT], Nut Proteins [EXT], Nut Proteins [EXT], Nut Proteins [EXT], Plant Proteins [CS], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63083-1013-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1013-2) </PackageDescription>
    <NDC11Code>63083-1013-02</NDC11Code>
    <ProductNDC>63083-1013</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Poison Ivy/oak</ProprietaryName>
    <ProprietaryNameSuffix>1013</ProprietaryNameSuffix>
    <NonProprietaryName>Poison Ivy/oak</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>ECHINACEA PURPUREA WHOLE; SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; BEEF LIVER; CROTON TIGLIUM SEED; HISTAMINE DIHYDROCHLORIDE; WOOD CREOSOTE; XEROPHYLLUM ASPHODELOIDES WHOLE; TOXICODENDRON DIVERSILOBUM LEAF; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA SUBSP. DIOICA LEAF; AILANTHUS ALTISSIMA FRUIT</SubstanceName>
    <StrengthNumber>2; 6; 6; 6; 8; 12; 12; 12; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63083-1015-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1015-2) </PackageDescription>
    <NDC11Code>63083-1015-02</NDC11Code>
    <ProductNDC>63083-1015</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sugar Mix</ProprietaryName>
    <ProprietaryNameSuffix>1015</ProprietaryNameSuffix>
    <NonProprietaryName>Sugar Mix</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>ANHYDROUS LACTOSE; ASPARTAME; BEEF LIVER; CORTICOTROPIN; DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; HISTAMINE DIHYDROCHLORIDE; HONEY; LIGHT BROWN SUGAR; MALTODEXTRIN; MALTOSE ANHYDROUS; MOLASSES; SACCHARIN; SUCRALOSE; SUCROSE; SUCROSE STEARATE; SUS SCROFA ADRENAL GLAND</SubstanceName>
    <StrengthNumber>6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of gas, bloating, diarrhea, and itching of the nose or throat due to sensitivity to sugars and sweeteners.*.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63083-1016-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1016-2) </PackageDescription>
    <NDC11Code>63083-1016-02</NDC11Code>
    <ProductNDC>63083-1016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trees 1</ProprietaryName>
    <ProprietaryNameSuffix>1016</ProprietaryNameSuffix>
    <NonProprietaryName>Trees 1</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ALNUS RHOMBIFOLIA BARK; FRAXINUS LATIFOLIA WHOLE; BETULA OCCIDENTALIS POLLEN; JUNIPERUS SCOPULORUM POLLEN; POPULUS TRICHOCARPA WHOLE; HESPEROCYPARIS ARIZONICA POLLEN; ELM; ABIES BALSAMEA LEAF OIL; PSEUDOTSUGA MENZIESII RESIN; CARYA LACINIOSA BARK; ACER PENSYLVANICUM WHOLE; WHITE MULBERRY; QUERCUS LOBATA POLLEN; QUERCUS VELUTINA POLLEN; PINUS STROBUS CONE; BIANCAEA SAPPAN WOOD; PICEA PUNGENS POLLEN</SubstanceName>
    <StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63083-1017-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1017-2) </PackageDescription>
    <NDC11Code>63083-1017-02</NDC11Code>
    <ProductNDC>63083-1017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trees 2</ProprietaryName>
    <ProprietaryNameSuffix>1017</ProprietaryNameSuffix>
    <NonProprietaryName>Trees 2</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACACIA; POPULUS TREMULOIDES POLLEN; BAY LEAF; SAMBUCUS NIGRA FLOWER; EUCALYPTUS GUM; FIG; DIANTHUS SUPERBUS FLOWERING TOP; MAGNOLIA X ALBA WHOLE; PROSOPIS CINERARIA WOOD; NERIUM OLEANDER WHOLE; GREEN OLIVE; BLACK PEPPER; LIGUSTRUM LUCIDUM SEED; SYMPHORICARPOS ALBUS FRUIT; LIRIODENDRON TULIPIFERA WHOLE; SALIX LUTEA POLLEN</SubstanceName>
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    <ProprietaryNameSuffix>1022</ProprietaryNameSuffix>
    <NonProprietaryName>Tropical</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>ACACIA; AMARANTHUS HYBRIDUS LEAF; AMBROSIA ARTEMISIIFOLIA WHOLE; ATRIPLEX POLYCARPA WHOLE; BEEF LIVER; CORTICOTROPIN; CYNODON DACTYLON WHOLE; EUCALYPTUS GUM; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS SCOPULORUM POLLEN; OLEA EUROPAEA FLOWER; PLANTAGO LANCEOLATA LEAF; POA PRATENSIS TOP; SUS SCROFA ADRENAL GLAND; SYAGRUS ROMANZOFFIANA WHOLE; WHITE MULBERRY; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN</SubstanceName>
    <StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Plant Proteins [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to sensitivity to common allergens in the tropics and Hawaii.*.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63083-1023-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1023-2) </PackageDescription>
    <NDC11Code>63083-1023-02</NDC11Code>
    <ProductNDC>63083-1023</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Smoke Mix</ProprietaryName>
    <ProprietaryNameSuffix>1023</ProprietaryNameSuffix>
    <NonProprietaryName>Smoke Mix</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>SUS SCROFA ADRENAL GLAND; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; BEEF LIVER; ACTIVATED CHARCOAL; ALOE SPICATA WHOLE; TOBACCO SMOKE; LIQUID PETROLEUM; NATURAL LATEX RUBBER; GUTTA PERCHA; TABTOXIN</SubstanceName>
    <StrengthNumber>6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>