NDC Code | 0121-0865-30 |
Package Description | 3 TRAY in 1 CASE (0121-0865-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05) |
Product NDC | 0121-0865 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Diphenhydramine Hcl |
Non-Proprietary Name | Diphenhydramine Hydrochloride |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20200618 |
Marketing Category Name | OTC MONOGRAPH DRUG |
Application Number | M012 |
Manufacturer | PAI Holdings, LLC dba PAI Pharma |
Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
Strength | 12.5 |
Strength Unit | mg/5mL |
Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |