RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>63083-2055-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-2055-2) </PackageDescription>
    <NDC11Code>63083-2055-02</NDC11Code>
    <ProductNDC>63083-2055</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neuro Relax Drops</ProprietaryName>
    <ProprietaryNameSuffix>2055</ProprietaryNameSuffix>
    <NonProprietaryName>Neuro Relax Drops</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>AVENA SATIVA FLOWERING TOP; ARTEMISIA ANNUA FLOWERING TOP; HOPS; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; PULSATILLA MONTANA WHOLE; ZINC</SubstanceName>
    <StrengthNumber>1; 1; 1; 1; 2; 2; 6; 6; 6; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant 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>36987-2055-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2055-2)</PackageDescription>
    <NDC11Code>36987-2055-02</NDC11Code>
    <ProductNDC>36987-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phoma Glomerata</ProprietaryName>
    <NonProprietaryName>Phoma Glomerata</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>PHOMA GLOMERATA</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-2055-2</NDCCode>
    <PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-2055-2) </PackageDescription>
    <NDC11Code>37662-2055-02</NDC11Code>
    <ProductNDC>37662-2055</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rhus Venenata</ProprietaryName>
    <NonProprietaryName>Rhus Venenata</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221206</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>TOXICODENDRON VERNIX LEAFY TWIG</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>48951-2055-2</NDCCode>
    <PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-2055-2) </PackageDescription>
    <NDC11Code>48951-2055-02</NDC11Code>
    <ProductNDC>48951-2055</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Berberis Quartz</ProprietaryName>
    <NonProprietaryName>Berberis Quartz</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>URIEL PHARMACY INC.</LabelerName>
    <SubstanceName>BERBERIS VULGARIS ROOT BARK; BOS TAURUS NASAL MUCOSA; SILICON DIOXIDE</SubstanceName>
    <StrengthNumber>3; 7; 20</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60219-2055-3</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3)  / 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-2055-03</NDC11Code>
    <ProductNDC>60219-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240527</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216343</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate ophthalmic gel forming solution, 0.25% and 0.5% is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate, USP has a molecular weight of 432.5 g/mol. Timolol maleate, USP is a white or almost white crystalline powder which is soluble in water, sparingly soluble in ethanol, slightly soluble in chloroform and practically insoluble in ether. Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths: 0.25% and 0.5%. Timolol maleate gel forming solution has a pH between 6.5 to 7.5 and an osmolality between 260 mOsmol/kg to 310 mOsmol/kg. Active:. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Preservative. Benzododecinium bromide, 0.12 mg (0.012%). Inactives. Xanthan gum, tromethamine, boric acid, mannitol, polysorbate-80, and water for injection. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>67938-2055-1</NDCCode>
    <PackageDescription>1 BOTTLE in 1 BOX (67938-2055-1)  &gt; 30 mL in 1 BOTTLE (67938-2055-2)</PackageDescription>
    <NDC11Code>67938-2055-01</NDC11Code>
    <ProductNDC>67938-2055</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Flawless Finish Perfectly Satinb 24hr Makeup Shade Bisque</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150105</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ELIZABETH ARDEN, INC</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>1.725; 1.346</StrengthNumber>
    <StrengthUnit>g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. 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>68745-2055-2</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68745-2055-2)  &gt; 20 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>68745-2055-02</NDC11Code>
    <ProductNDC>68745-2055</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Les Beiges</ProprietaryName>
    <ProprietaryNameSuffix>Healthy Glow Foundation Broad Spectrum Spf 25 Sunscreen No 60</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160504</StartMarketingDate>
    <EndMarketingDate>20201231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>CHANEL PARFUMS BEAUTE</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>60; 56</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160504</StartMarketingDatePackage>
    <EndMarketingDatePackage>20201231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-2055-2</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71335-2055-2) </PackageDescription>
    <NDC11Code>71335-2055-02</NDC11Code>
    <ProductNDC>71335-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207408</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: anhydrous dibasic calcium phosphate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microscrystalline cellulose, titanium dioxide, and triacetin; in addition, the 5 mg and 40 mg strengths contain ferric oxide red, and the 10 mg and 20 mg strength contain ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-2055-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0093-2055-05)</PackageDescription>
    <NDC11Code>00093-2055-05</NDC11Code>
    <ProductNDC>0093-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120511</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020771</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA Inc</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-28</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0093-2055-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0093-2055-06)</PackageDescription>
    <NDC11Code>00093-2055-06</NDC11Code>
    <ProductNDC>0093-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120511</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020771</ApplicationNumber>
    <LabelerName>Teva Pharmaceuticals USA Inc</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-28</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0093-2055-42</NDCCode>
    <PackageDescription>140 BLISTER PACK in 1 CARTON (0093-2055-42)  &gt; 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-2055-19)</PackageDescription>
    <NDC11Code>00093-2055-42</NDC11Code>
    <ProductNDC>0093-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tolterodine Tartrate</ProprietaryName>
    <NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120511</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020771</ApplicationNumber>
    <LabelerName>TEVA Pharmaceuticals USA Inc</LabelerName>
    <SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-09-04</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0440-2055-40</NDCCode>
    <PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (0440-2055-40)</PackageDescription>
    <NDC11Code>00440-2055-40</NDC11Code>
    <ProductNDC>0440-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Penicillin V Potassium</ProprietaryName>
    <NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20040201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062936</ApplicationNumber>
    <LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and Penicillin V Potassium for Oral Solution 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following Infections will usually respond to adequate dosage of Penicillin V. Streptococcal infections (without bacteremia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus) are resistant. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections - penicillin G sensitive: Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis. For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association.1.</IndicationAndUsage>
    <Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V Potassium is designated chemically as 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo- 6-[(phenoxyacetyl)amino]-, monopotassium salt, [2S-(2α,5α,6β)]-. It has the following chemical structure. The molecular formula is C16H17KN2O5S, and the molecular weight is 388.48. Each tablet contains Penicillin V Potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) of penicillin V. Each Penicillin V Potassium tablet, USP, 250 mg contains 0.73 mEq (28.2 mg) of Potassium and each Penicillin V potassium tablet, USP, 500 mg contains 1.46 mEq (56.4 mg) of Potassium. Each tablet also contains the following inactive ingredients: lactose, NF; magnesium stearate, NF; microcrystalline cellulose, NF; polyethylene glycol, NF; povidone, USP; sodium laurel sulfate, NF. Each 5 mL when reconstituted as directed contains Penicillin V Potassium equivalent to 125 mg or 250 mg (200,000 or 400,000 units) of Penicillin V. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP,125 mg per 5 mL contains 0.42 mEq (16.4 mg) of Potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution, USP, 250 mg per 5 mL contains 0.85 mEq (32.8 mg) of Potassium. Each 5 mL of reconstituted suspension also contains the following inactive ingredients: aspartame, NF; citric acid, USP; FD&amp;C Red No. 40; flavors; primary taste modifier; saccharin sodium, USP; silicon dioxide, NF; sodium citrate, USP; sodium propionate, NF; sucrose, NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>63083-1001-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1001-2) </PackageDescription>
    <NDC11Code>63083-1001-02</NDC11Code>
    <ProductNDC>63083-1001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pets</ProprietaryName>
    <ProprietaryNameSuffix>1001</ProprietaryNameSuffix>
    <NonProprietaryName>Pets</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; CAMELUS BACTRIANUS HAIR; FELIS CATUS HAIR; BOVINE TYPE I COLLAGEN (SKIN); CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; BLUEGILL; CAPRA HIRCUS HAIR; CAVIA PORCELLUS WHOLE; SUS SCROFA HAIR; HORSE; RABBIT; SHEEP WOOL</SubstanceName>
    <StrengthNumber>6; 6; 12; 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</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], Animal Fur [CS], Animal Fur [CS], Animal Fur [CS], Animal Fur [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], Dander [CS], Dietary Proteins [CS], Dietary Proteins [CS], Feathers [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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Animal Hair Allergenic Extract [EPC], Non-Standardized Feather Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Salivary Proteins and Peptides [CS], Standardized Animal Hair 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>63083-1002-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1002-2) </PackageDescription>
    <NDC11Code>63083-1002-02</NDC11Code>
    <ProductNDC>63083-1002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biting Insect Mix</ProprietaryName>
    <ProprietaryNameSuffix>1002</ProprietaryNameSuffix>
    <NonProprietaryName>Biting Insect 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; SOLENOPSIS INVICTA; APIS CERANA WHOLE; PERIPLANETA AUSTRALASIAE; TABANUS NIGROVITTATUS; CTENOCEPHALIDES CANIS; MUSCA DOMESTICA; CULEX PIPIENS; BOMBYX MORI WHOLE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; POLISTES FUSCATUS WHOLE</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], Allergens [CS], Allergens [CS], Ant Venoms [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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Venom 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>63083-1003-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1003-2) </PackageDescription>
    <NDC11Code>63083-1003-02</NDC11Code>
    <ProductNDC>63083-1003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Caffeine Mix</ProprietaryName>
    <ProprietaryNameSuffix>1003</ProprietaryNameSuffix>
    <NonProprietaryName>Caffeine 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; CAFFEINE; COCOA; COFFEE BEAN; HIGH FRUCTOSE CORN SYRUP; TEA LEAF</SubstanceName>
    <StrengthNumber>6; 6; 12; 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</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], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [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], Methylxanthine [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], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Xanthines [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>63083-1004-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1004-2) </PackageDescription>
    <NDC11Code>63083-1004-02</NDC11Code>
    <ProductNDC>63083-1004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dairy Mix</ProprietaryName>
    <ProprietaryNameSuffix>1004</ProprietaryNameSuffix>
    <NonProprietaryName>Dairy 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; 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>
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    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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    <ProprietaryName>Poison Ivy/oak</ProprietaryName>
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    <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>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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    <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>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <SamplePackage>N</SamplePackage>
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    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <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>
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    <ProprietaryNameSuffix>1017</ProprietaryNameSuffix>
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    <RouteName>ORAL</RouteName>
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    <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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    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <NDC11Code>63083-1018-02</NDC11Code>
    <ProductNDC>63083-1018</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vegetable Mix</ProprietaryName>
    <ProprietaryNameSuffix>1018</ProprietaryNameSuffix>
    <NonProprietaryName>Vegetable 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; ASPARAGUS; LIMA BEAN; BEET; BROCCOLI; CABBAGE; CARROT; CAULIFLOWER; CELERY; CORN; CUCUMBER; GARLIC; KALE; LENTIL; LETTUCE; ONION; PARSNIP; CHICKPEA; PEPPERS; POTATO; RADISH; SOYBEAN; SPINACH; TURNIP</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</StrengthNumber>
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    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
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    <NDC11Code>63083-1019-02</NDC11Code>
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    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
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    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1020-2) </PackageDescription>
    <NDC11Code>63083-1020-02</NDC11Code>
    <ProductNDC>63083-1020</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Southwest Regional</ProprietaryName>
    <ProprietaryNameSuffix>1020</ProprietaryNameSuffix>
    <NonProprietaryName>Southwest Regional</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
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    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>63083-1021-2</NDCCode>
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    <NDC11Code>63083-1021-02</NDC11Code>
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    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Northeast Regional</ProprietaryName>
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    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
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    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>63083-1022-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1022-2) </PackageDescription>
    <NDC11Code>63083-1022-02</NDC11Code>
    <ProductNDC>63083-1022</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tropical</ProprietaryName>
    <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>
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    <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>
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    <NDCCode>63083-1023-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1023-2) </PackageDescription>
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    <ProductNDC>63083-1023</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Smoke Mix</ProprietaryName>
    <ProprietaryNameSuffix>1023</ProprietaryNameSuffix>
    <NonProprietaryName>Smoke Mix</NonProprietaryName>
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    <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>
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    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
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    <NDCCode>63083-1024-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, DROPPER (63083-1024-2) </PackageDescription>
    <NDC11Code>63083-1024-02</NDC11Code>
    <ProductNDC>63083-1024</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Southeast Regional</ProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
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    <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], Allergens [CS], Allergens [Chemical/Ingredient], 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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], 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], 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], Increased IgG Production [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], Increased IgG Production [PE], Increased IgG Production [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 Plant Allergenic Extract [EPC], Non-Standardized Plant 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], 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], Nut Proteins [EXT], Plant Proteins [CS], Plant Proteins [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [Chemical/Ingredient]</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>