| NDC Code | 57237-312-51 |
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| Package Description | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05) |
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| Product NDC | 57237-312 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Dextromethorphan Hbr. And Guaifenesin |
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| Non-Proprietary Name | Dextromethorphan Hbr. And Guaifenesin |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20230612 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012.85 |
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| Manufacturer | Rising Pharma Holdings, Inc. |
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| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
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| Strength | 10; 100 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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