{
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"SamplePackage": "N",
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"NDCCode": "63388-920-49",
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"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
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"StrengthUnit": "[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL",
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"PackageNdcExcludeFlag": "N",
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},
{
"NDCCode": "63388-910-44",
"PackageDescription": "30 mL in 1 BOTTLE (63388-910-44) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE",
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"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
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"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares."
},
{
"NDCCode": "63388-910-45",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-910-45) / 100 mL in 1 BOTTLE",
"NDC11Code": "63388-0910-45",
"ProductNDC": "63388-910",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Relief",
"NonProprietaryName": "Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus",
"DosageFormName": "LIQUID",
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"StartMarketingDate": "20180303",
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"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE",
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"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
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"LastUpdate": "2025-10-13",
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"IndicationAndUsage": "Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares."
},
{
"NDCCode": "10345-910-01",
"PackageDescription": "1.5 mL in 1 PACKET (10345-910-01) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "LABORATOIRES M&L",
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"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2024-12-13",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20171203",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "10345-910-05",
"PackageDescription": "1 TUBE in 1 BOX (10345-910-05) / 5 mL in 1 TUBE",
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"ProductTypeName": "HUMAN OTC DRUG",
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"StartMarketingDatePackage": "20180701",
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"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
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"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "10345-910-45",
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"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "63388-643-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (63388-643-02) / 25 mL in 1 BOTTLE",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Gas And Colic Relief",
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"LabelerName": "Laboratoire Atlas Inc",
"SubstanceName": "CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC; CHAMOMILE; DIOSCOREA VILLOSA ROOT",
"StrengthNumber": "6; 6; 6; 6",
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"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20140219",
"SamplePackage": "N",
"IndicationAndUsage": "This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic. intestinal gas. abdominal pain. bloating & hiccups. nausea. burping. upset stomach. *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice."
},
{
"NDCCode": "63388-912-14",
"PackageDescription": "30 mL in 1 BOTTLE (63388-912-14) ",
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{
"NDCCode": "63388-912-15",
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},
{
"NDCCode": "63388-912-19",
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},
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"NDCCode": "63388-915-14",
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"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold. dry cough cough with expectoration. chest congestion fever aches and pains."
},
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"NDCCode": "63388-915-15",
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<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>1; 3; 3; 3; 1; 3; 3; 3; 4; 4</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-910-44</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63388-910-44) </PackageDescription>
<NDC11Code>63388-0910-44</NDC11Code>
<ProductNDC>63388-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-910-45</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-910-45) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0910-45</NDC11Code>
<ProductNDC>63388-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Asafoetida, Ignatia Amara, Valeriana Officinalis, Avena Sativa, Argentum Nitricum, Hyoscyamus Niger, Paeonia Officinalis, Stramonium, Cocculus Indicus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLE; OAT BRAN; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS WHOLE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of. Restlessness nervousness irritability. agitation sleeplessness lessens nightmares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10345-910-01</NDCCode>
<PackageDescription>1.5 mL in 1 PACKET (10345-910-01) </PackageDescription>
<NDC11Code>10345-0910-01</NDC11Code>
<ProductNDC>10345-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Erborian - Cc Creme High Definition Spf 25</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>LABORATOIRES M&L</LabelerName>
<SubstanceName>OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>20; 60; 49.7; 19.2</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171203</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10345-910-05</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10345-910-05) / 5 mL in 1 TUBE</PackageDescription>
<NDC11Code>10345-0910-05</NDC11Code>
<ProductNDC>10345-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Erborian - Cc Creme High Definition Spf 25</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>LABORATOIRES M&L</LabelerName>
<SubstanceName>OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>20; 60; 49.7; 19.2</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10345-910-15</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10345-910-15) / 15 mL in 1 TUBE</PackageDescription>
<NDC11Code>10345-0910-15</NDC11Code>
<ProductNDC>10345-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Erborian - Cc Creme High Definition Spf 25</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>LABORATOIRES M&L</LabelerName>
<SubstanceName>OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>20; 60; 49.7; 19.2</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10345-910-45</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10345-910-45) / 45 mL in 1 TUBE</PackageDescription>
<NDC11Code>10345-0910-45</NDC11Code>
<ProductNDC>10345-910</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Erborian - Cc Creme High Definition Spf 25</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>LABORATOIRES M&L</LabelerName>
<SubstanceName>OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>20; 60; 49.7; 19.2</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection mesures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-643-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-643-02) / 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0643-02</NDC11Code>
<ProductNDC>63388-643</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Gas And Colic Relief</ProprietaryName>
<NonProprietaryName>Colocynthis, Magnesia Phosphorica, Chamomilla, Dioscorea Villosa</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC; CHAMOMILE; DIOSCOREA VILLOSA ROOT</SubstanceName>
<StrengthNumber>6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic. intestinal gas. abdominal pain. bloating & hiccups. nausea. burping. upset stomach. *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-912-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63388-912-14) </PackageDescription>
<NDC11Code>63388-0912-14</NDC11Code>
<ProductNDC>63388-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; CORALLIUM RUBRUM WHOLE; TIN</SubstanceName>
<StrengthNumber>1; 3; 3; 3; 1; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses This homeopathic medicine is made from a. combination of ingredients traditionally used to help. relieve symptoms associated with cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-912-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-912-15) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0912-15</NDC11Code>
<ProductNDC>63388-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; CORALLIUM RUBRUM WHOLE; TIN</SubstanceName>
<StrengthNumber>1; 3; 3; 3; 1; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses This homeopathic medicine is made from a. combination of ingredients traditionally used to help. relieve symptoms associated with cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-912-19</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-912-19) / 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0912-19</NDC11Code>
<ProductNDC>63388-912</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Ipecacuanha, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; CORALLIUM RUBRUM WHOLE; TIN</SubstanceName>
<StrengthNumber>1; 3; 3; 3; 1; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses This homeopathic medicine is made from a. combination of ingredients traditionally used to help. relieve symptoms associated with cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-915-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63388-915-14) </PackageDescription>
<NDC11Code>63388-0915-14</NDC11Code>
<ProductNDC>63388-915</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Chamomilla, Coffee Crudea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; TIN; CHAMOMILE; ARABICA COFFEE BEAN; CORALLIUM RUBRUM WHOLE</SubstanceName>
<StrengthNumber>1; 3; 3; 1; 3; 3; 4; 4; 3</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-915-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-915-15) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0915-15</NDC11Code>
<ProductNDC>63388-915</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
<NonProprietaryName>Drosera, Arnica Montana, Bryonia, Cetraria Islandica, Coccus Cacti, Corallium Rubrum, Stannum Metallicum, Chamomilla, Coffee Crudea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; TIN; CHAMOMILE; ARABICA COFFEE BEAN; CORALLIUM RUBRUM WHOLE</SubstanceName>
<StrengthNumber>1; 3; 3; 1; 3; 3; 4; 4; 3</StrengthNumber>
<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63388-915-19</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63388-915-19) / 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63388-0915-19</NDC11Code>
<ProductNDC>63388-915</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Relief</ProprietaryName>
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<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; TIN; CHAMOMILE; ARABICA COFFEE BEAN; CORALLIUM RUBRUM WHOLE</SubstanceName>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
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<LabelerName>Laboratoire Atlas Inc</LabelerName>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains.</IndicationAndUsage>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
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<ProprietaryName>Real Relief</ProprietaryName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: This homeopathic medicine is made from a combination of. ingredients traditionally used to help symptoms assiciated with. cough and cold* dry cough expectorant cough chest. congestion fever aches and pains.</IndicationAndUsage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Real Relief</ProprietaryName>
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<LabelerName>Laboratoire Atlas Inc</LabelerName>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
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<LabelerName>Laboratoire Atlas Inc</LabelerName>
<SubstanceName>DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM WHOLE; TIN; CHAMOMILE; ARABICA COFFEE BEAN</SubstanceName>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
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<LastUpdate>2025-10-13</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesThis homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
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<StrengthUnit>[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses This homeopathic medicine is made from a combination. of ingredients traditionally used to help relieve. symptoms associated with nighttime cough and cold*. dry cough cough with expectoration. chest congestion fever aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
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<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include corn starch, hypromellose type 2,910/3 cP, 5 cP, 6 cP and 50 cP, methacrylic acid copolymer type C, polydextrose, polyethylene glycol/macrogol, red iron oxide, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The capsule shells contain gelatin and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsule shells also contain FD&C Blue No. 1. The 20 mg, 25 mg and 30 mg capsule shells also contain black iron oxide, red iron oxide, and yellow iron oxide. Additionally, the capsule imprint ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
</NDC>
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<SamplePackage>N</SamplePackage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include corn starch, hypromellose type 2,910/3 cP, 5 cP, 6 cP and 50 cP, methacrylic acid copolymer type C, polydextrose, polyethylene glycol/macrogol, red iron oxide, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The capsule shells contain gelatin and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsule shells also contain FD&C Blue No. 1. The 20 mg, 25 mg and 30 mg capsule shells also contain black iron oxide, red iron oxide, and yellow iron oxide. Additionally, the capsule imprint ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
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<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
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<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include corn starch, hypromellose type 2,910/3 cP, 5 cP, 6 cP and 50 cP, methacrylic acid copolymer type C, polydextrose, polyethylene glycol/macrogol, red iron oxide, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The capsule shells contain gelatin and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsule shells also contain FD&C Blue No. 1. The 20 mg, 25 mg and 30 mg capsule shells also contain black iron oxide, red iron oxide, and yellow iron oxide. Additionally, the capsule imprint ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
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<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
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<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include corn starch, hypromellose type 2,910/3 cP, 5 cP, 6 cP and 50 cP, methacrylic acid copolymer type C, polydextrose, polyethylene glycol/macrogol, red iron oxide, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The capsule shells contain gelatin and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsule shells also contain FD&C Blue No. 1. The 20 mg, 25 mg and 30 mg capsule shells also contain black iron oxide, red iron oxide, and yellow iron oxide. Additionally, the capsule imprint ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
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<NDC>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (0115-1490-01) </PackageDescription>
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<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
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<DEASchedule>CII</DEASchedule>
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<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include corn starch, hypromellose type 2,910/3 cP, 5 cP, 6 cP and 50 cP, methacrylic acid copolymer type C, polydextrose, polyethylene glycol/macrogol, red iron oxide, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The capsule shells contain gelatin and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsule shells also contain FD&C Blue No. 1. The 20 mg, 25 mg and 30 mg capsule shells also contain black iron oxide, red iron oxide, and yellow iron oxide. Additionally, the capsule imprint ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (0115-1491-01) </PackageDescription>
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<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
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<LastUpdate>2026-07-03</LastUpdate>
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<SamplePackage>N</SamplePackage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the ADDERALL (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) (immediate-release) tablet formulation. Each capsule contains. Inactive Ingredients and Colors. The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include corn starch, hypromellose type 2,910/3 cP, 5 cP, 6 cP and 50 cP, methacrylic acid copolymer type C, polydextrose, polyethylene glycol/macrogol, red iron oxide, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The capsule shells contain gelatin and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsule shells also contain FD&C Blue No. 1. The 20 mg, 25 mg and 30 mg capsule shells also contain black iron oxide, red iron oxide, and yellow iron oxide. Additionally, the capsule imprint ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
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