| NDC Code | 0121-0865-00 |
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| Package Description | 10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05) |
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| Product NDC | 0121-0865 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Diphenhydramine Hcl |
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| Non-Proprietary Name | Diphenhydramine Hydrochloride |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20200618 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | M012 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
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| Strength | 12.5 |
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| Strength Unit | mg/5mL |
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| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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