{
"NDC": [
{
"NDCCode": "0603-0268-32",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0603-0268-32)",
"NDC11Code": "00603-0268-32",
"ProductNDC": "0603-0268",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Qpap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110602",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0268-0603-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0603-10) ",
"NDC11Code": "00268-0603-10",
"ProductNDC": "0268-0603",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Bos Taurus Skin",
"NonProprietaryName": "Cattle Epithelia",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "BOS TAURUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
"Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
},
{
"NDCCode": "0268-0603-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0603-50) ",
"NDC11Code": "00268-0603-50",
"ProductNDC": "0268-0603",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Bos Taurus Skin",
"NonProprietaryName": "Cattle Epithelia",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "BOS TAURUS SKIN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
"Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
},
{
"NDCCode": "0603-0268-29",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0603-0268-29)",
"NDC11Code": "00603-0268-29",
"ProductNDC": "0603-0268",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Qpap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110602",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0268-8001-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8001-30) ",
"NDC11Code": "00268-8001-30",
"ProductNDC": "0268-8001",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "3 Grass Mix",
"NonProprietaryName": "Bromus Inermis Pollen, Cynodon Dactylon, Cynodon Dactylon",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "BROMUS INERMIS POLLEN; CYNODON DACTYLON WHOLE; SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "20000; 20000; 20000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [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], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8004-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8004-30) ",
"NDC11Code": "00268-8004-30",
"ProductNDC": "0268-8004",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "4 Weed Mix",
"NonProprietaryName": "Amaranthus Retroflexus Pollen, Chenopodium Album Pollen, Plantago Lanceolata Pollen, Xanthium Strumarium Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; PLANTAGO LANCEOLATA POLLEN; XANTHIUM STRUMARIUM POLLEN",
"StrengthNumber": "10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [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], 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]",
"Status": "Deprecated",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
"Description": "Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content."
},
{
"NDCCode": "0268-8008-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8008-30) ",
"NDC11Code": "00268-8008-30",
"ProductNDC": "0268-8008",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "5 Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Phleum Pratense, Poa Pratensis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; PHLEUM PRATENSE; POA PRATENSIS",
"StrengthNumber": "10000; 10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
"Description": "Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content."
},
{
"NDCCode": "0268-8009-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8009-30) ",
"NDC11Code": "00268-8009-30",
"ProductNDC": "0268-8009",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "5 Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Phleum Pratense, Poa Pratensis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; PHLEUM PRATENSE; POA PRATENSIS",
"StrengthNumber": "20000; 20000; 20000; 20000; 20000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8011-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8011-30) ",
"NDC11Code": "00268-8011-30",
"ProductNDC": "0268-8011",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "6 Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS",
"StrengthNumber": "10000; 10000; 10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8012-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8012-30) ",
"NDC11Code": "00268-8012-30",
"ProductNDC": "0268-8012",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "6 Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS",
"StrengthNumber": "20000; 20000; 20000; 20000; 20000; 20000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8013-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8013-30) ",
"NDC11Code": "00268-8013-30",
"ProductNDC": "0268-8013",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "7 Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS",
"StrengthNumber": "10000; 10000; 10000; 10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8014-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8014-30) ",
"NDC11Code": "00268-8014-30",
"ProductNDC": "0268-8014",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "7 Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS",
"StrengthNumber": "20000; 20000; 20000; 20000; 20000; 20000; 20000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8015-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8015-30) ",
"NDC11Code": "00268-8015-30",
"ProductNDC": "0268-8015",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "8 Southern Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; CYNODON DACTYLON WHOLE; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS; SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8016-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8016-30) ",
"NDC11Code": "00268-8016-30",
"ProductNDC": "0268-8016",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "8 Southern Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; CYNODON DACTYLON WHOLE; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS; SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8017-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8017-30) ",
"NDC11Code": "00268-8017-30",
"ProductNDC": "0268-8017",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "9 Southern Grass Mix",
"NonProprietaryName": "Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; CYNODON DACTYLON WHOLE; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS; SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-8023-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8023-30) ",
"NDC11Code": "00268-8023-30",
"ProductNDC": "0268-8023",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "9 Tree Mix",
"NonProprietaryName": "Acer Saccharum Pollen, Alnus Rhombifolia Pollen, Betula Lenta Pollen, Carya Ovata Pollen, Fraxinus Americana Pollen, Platanus Occidentalis Pollen, Populus Alba Pollen, Quercus Alba Pollen, Ulmus Americana Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "ACER SACCHARUM POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA LENTA POLLEN; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN",
"StrengthNumber": "10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "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], 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], 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], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
"Description": "Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content."
},
{
"NDCCode": "0268-8057-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8057-30) ",
"NDC11Code": "00268-8057-30",
"ProductNDC": "0268-8057",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Mixed Ragweed",
"NonProprietaryName": "Ambrosia Artemisiifolia, Ambrosia Trifida Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN",
"StrengthNumber": "10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
"Description": "Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content."
},
{
"NDCCode": "0268-8058-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8058-30) ",
"NDC11Code": "00268-8058-30",
"ProductNDC": "0268-8058",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Mixed Ragweed",
"NonProprietaryName": "Ambrosia Artemisiifolia, Ambrosia Trifida Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN",
"StrengthNumber": "20000; 20000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.",
"Description": "Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content."
},
{
"NDCCode": "0268-8079-30",
"PackageDescription": "32 mL in 1 VIAL (0268-8079-30) ",
"NDC11Code": "00268-8079-30",
"ProductNDC": "0268-8079",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Western Weed Mix",
"NonProprietaryName": "Ambrosia Acanthicarpa Pollen, Ambrosia Psilostachya Pollen, Artemisia Tridentata Pollen, Bassia Scoparia Pollen, Salsola Kali Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "AMBROSIA ACANTHICARPA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ARTEMISIA TRIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; SALSOLA KALI POLLEN",
"StrengthNumber": "10000; 10000; 10000; 10000; 10000",
"StrengthUnit": "[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL",
"Pharm_Classes": "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], 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], 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]",
"Status": "Deprecated",
"LastUpdate": "2023-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0268-32",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (0363-0268-32) ",
"NDC11Code": "00363-0268-32",
"ProductNDC": "0363-0268",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"ProprietaryNameSuffix": "3 Percent",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Walgreens",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "2.65",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth."
},
{
"NDCCode": "11673-268-32",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (11673-268-32) ",
"NDC11Code": "11673-0268-32",
"ProductNDC": "11673-268",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"ProprietaryNameSuffix": "3 Percent",
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"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "TARGET Corporation",
"SubstanceName": "HYDROGEN PEROXIDE",
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"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150831",
"SamplePackage": "N",
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},
{
"NDCCode": "41250-268-32",
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"ProductNDC": "41250-268",
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"ProprietaryNameSuffix": "3 Percent",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "MEIJER, INC.",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "3",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190630",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth."
},
{
"NDCCode": "42507-268-32",
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"ProductNDC": "42507-268",
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"ProprietaryName": "Hydrogen Peroxide",
"ProprietaryNameSuffix": "3 Percent",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141031",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Hy-Vee",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "2.65",
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"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141031",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "49035-268-32",
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"NDC11Code": "49035-0268-32",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20140530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)",
"SubstanceName": "HYDROGEN PEROXIDE",
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"StrengthUnit": "mL/100mL",
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"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140530",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth."
},
{
"NDCCode": "49738-268-32",
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"ProprietaryNameSuffix": "3 Percent",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20150131",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "SMART SENSE (Kmart)",
"SubstanceName": "HYDROGEN PEROXIDE",
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"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150131",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "51316-268-32",
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"NDC11Code": "51316-0268-32",
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"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20221130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "CVS PHARMACY, INC",
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"StrengthNumber": "3",
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"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20221130",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes, and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth."
},
{
"NDCCode": "55312-268-32",
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"ProductNDC": "55312-268",
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"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141031",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Western Family Foods, Inc.",
"SubstanceName": "HYDROGEN PEROXIDE",
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"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141031",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "55315-268-32",
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"NDC11Code": "55315-0268-32",
"ProductNDC": "55315-268",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20141231",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Freds Inc",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "2.65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141231",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
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},
{
"NDCCode": "55319-268-32",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20140831",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Family Dollar (FAMILY WELLNESS)",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "2.65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140831",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes, and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth."
},
{
"NDCCode": "55910-268-32",
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"NDC11Code": "55910-0268-32",
"ProductNDC": "55910-268",
"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "3 Percent",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200730",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "2.65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200730",
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"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0603-0268-32</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0603-0268-32)</PackageDescription>
<NDC11Code>00603-0268-32</NDC11Code>
<ProductNDC>0603-0268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Qpap</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Qualitest Pharmaceuticals</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0268-0603-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0603-10) </PackageDescription>
<NDC11Code>00268-0603-10</NDC11Code>
<ProductNDC>0268-0603</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Bos Taurus Skin</ProprietaryName>
<NonProprietaryName>Cattle Epithelia</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
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<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
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<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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</NDC>
<NDC>
<NDCCode>0268-0603-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0603-50) </PackageDescription>
<NDC11Code>00268-0603-50</NDC11Code>
<ProductNDC>0268-0603</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Bos Taurus Skin</ProprietaryName>
<NonProprietaryName>Cattle Epithelia</NonProprietaryName>
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<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
</NDC>
<NDC>
<NDCCode>0603-0268-29</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0603-0268-29)</PackageDescription>
<NDC11Code>00603-0268-29</NDC11Code>
<ProductNDC>0603-0268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Qpap</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110602</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Qualitest Pharmaceuticals</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0268-8001-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8001-30) </PackageDescription>
<NDC11Code>00268-8001-30</NDC11Code>
<ProductNDC>0268-8001</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>3 Grass Mix</ProprietaryName>
<NonProprietaryName>Bromus Inermis Pollen, Cynodon Dactylon, Cynodon Dactylon</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>BROMUS INERMIS POLLEN; CYNODON DACTYLON WHOLE; SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>20000; 20000; 20000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [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], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8004-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8004-30) </PackageDescription>
<NDC11Code>00268-8004-30</NDC11Code>
<ProductNDC>0268-8004</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>4 Weed Mix</ProprietaryName>
<NonProprietaryName>Amaranthus Retroflexus Pollen, Chenopodium Album Pollen, Plantago Lanceolata Pollen, Xanthium Strumarium Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; PLANTAGO LANCEOLATA POLLEN; XANTHIUM STRUMARIUM POLLEN</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [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], 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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.</IndicationAndUsage>
<Description>Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content.</Description>
</NDC>
<NDC>
<NDCCode>0268-8008-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8008-30) </PackageDescription>
<NDC11Code>00268-8008-30</NDC11Code>
<ProductNDC>0268-8008</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>5 Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Phleum Pratense, Poa Pratensis</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; PHLEUM PRATENSE; POA PRATENSIS</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Description>Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content.</Description>
</NDC>
<NDC>
<NDCCode>0268-8009-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8009-30) </PackageDescription>
<NDC11Code>00268-8009-30</NDC11Code>
<ProductNDC>0268-8009</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>5 Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Phleum Pratense, Poa Pratensis</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; PHLEUM PRATENSE; POA PRATENSIS</SubstanceName>
<StrengthNumber>20000; 20000; 20000; 20000; 20000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8011-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8011-30) </PackageDescription>
<NDC11Code>00268-8011-30</NDC11Code>
<ProductNDC>0268-8011</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>6 Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8012-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8012-30) </PackageDescription>
<NDC11Code>00268-8012-30</NDC11Code>
<ProductNDC>0268-8012</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>6 Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS</SubstanceName>
<StrengthNumber>20000; 20000; 20000; 20000; 20000; 20000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8013-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8013-30) </PackageDescription>
<NDC11Code>00268-8013-30</NDC11Code>
<ProductNDC>0268-8013</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>7 Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8014-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8014-30) </PackageDescription>
<NDC11Code>00268-8014-30</NDC11Code>
<ProductNDC>0268-8014</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>7 Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS</SubstanceName>
<StrengthNumber>20000; 20000; 20000; 20000; 20000; 20000; 20000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8015-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8015-30) </PackageDescription>
<NDC11Code>00268-8015-30</NDC11Code>
<ProductNDC>0268-8015</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>8 Southern Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; CYNODON DACTYLON WHOLE; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS; SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8016-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8016-30) </PackageDescription>
<NDC11Code>00268-8016-30</NDC11Code>
<ProductNDC>0268-8016</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>8 Southern Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; CYNODON DACTYLON WHOLE; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS; SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8017-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8017-30) </PackageDescription>
<NDC11Code>00268-8017-30</NDC11Code>
<ProductNDC>0268-8017</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>9 Southern Grass Mix</ProprietaryName>
<NonProprietaryName>Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM; CYNODON DACTYLON WHOLE; DACTYLIS GLOMERATA; FESTUCA PRATENSIS; LOLIUM PERENNE; PHLEUM PRATENSE; POA PRATENSIS; SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-8023-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8023-30) </PackageDescription>
<NDC11Code>00268-8023-30</NDC11Code>
<ProductNDC>0268-8023</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>9 Tree Mix</ProprietaryName>
<NonProprietaryName>Acer Saccharum Pollen, Alnus Rhombifolia Pollen, Betula Lenta Pollen, Carya Ovata Pollen, Fraxinus Americana Pollen, Platanus Occidentalis Pollen, Populus Alba Pollen, Quercus Alba Pollen, Ulmus Americana Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA LENTA POLLEN; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>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], 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], 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], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.</IndicationAndUsage>
<Description>Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content.</Description>
</NDC>
<NDC>
<NDCCode>0268-8057-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8057-30) </PackageDescription>
<NDC11Code>00268-8057-30</NDC11Code>
<ProductNDC>0268-8057</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Mixed Ragweed</ProprietaryName>
<NonProprietaryName>Ambrosia Artemisiifolia, Ambrosia Trifida Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN</SubstanceName>
<StrengthNumber>10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.</IndicationAndUsage>
<Description>Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content.</Description>
</NDC>
<NDC>
<NDCCode>0268-8058-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8058-30) </PackageDescription>
<NDC11Code>00268-8058-30</NDC11Code>
<ProductNDC>0268-8058</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Mixed Ragweed</ProprietaryName>
<NonProprietaryName>Ambrosia Artemisiifolia, Ambrosia Trifida Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN</SubstanceName>
<StrengthNumber>20000; 20000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.</IndicationAndUsage>
<Description>Center-Al® (Allergenic extracts, Alum Precipitated) is prepared from aqueous allergenic extracts by the formation of an aluminum hydroxide precipitated complex. It is supplied as a sterile suspension in multiple dose vials for subcutaneous injection. 0.4% Phenol is added as a preservative. This product is compounded and diluted on a PNU basis. Extracts containing Short Ragweed Pollen also bear a labeled potency declaration in terms of Antigen E content.</Description>
</NDC>
<NDC>
<NDCCode>0268-8079-30</NDCCode>
<PackageDescription>32 mL in 1 VIAL (0268-8079-30) </PackageDescription>
<NDC11Code>00268-8079-30</NDC11Code>
<ProductNDC>0268-8079</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Western Weed Mix</ProprietaryName>
<NonProprietaryName>Ambrosia Acanthicarpa Pollen, Ambrosia Psilostachya Pollen, Artemisia Tridentata Pollen, Bassia Scoparia Pollen, Salsola Kali Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>AMBROSIA ACANTHICARPA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ARTEMISIA TRIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; SALSOLA KALI POLLEN</SubstanceName>
<StrengthNumber>10000; 10000; 10000; 10000; 10000</StrengthNumber>
<StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
<Pharm_Classes>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], 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], 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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0268-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (0363-0268-32) </PackageDescription>
<NDC11Code>00363-0268-32</NDC11Code>
<ProductNDC>0363-0268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<ProprietaryNameSuffix>3 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>2.65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent the risk of infection in minor cuts, scrapes and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-268-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (11673-268-32) </PackageDescription>
<NDC11Code>11673-0268-32</NDC11Code>
<ProductNDC>11673-268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<ProprietaryNameSuffix>3 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>2.65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent the risk of infection in minor cuts, scrapes and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41250-268-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (41250-268-32) </PackageDescription>
<NDC11Code>41250-0268-32</NDC11Code>
<ProductNDC>41250-268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<ProprietaryNameSuffix>3 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>MEIJER, INC.</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent the risk of infection in minor cuts, scrapes and burns. aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42507-268-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (42507-268-32) </PackageDescription>
<NDC11Code>42507-0268-32</NDC11Code>
<ProductNDC>42507-268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<ProprietaryNameSuffix>3 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Hy-Vee</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>2.65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141031</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49035-268-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (49035-268-32) </PackageDescription>
<NDC11Code>49035-0268-32</NDC11Code>
<ProductNDC>49035-268</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<ProprietaryNameSuffix>3 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
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