NDC Code | 57237-317-51 |
Package Description | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-317-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-317-05) |
Product NDC | 57237-317 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Diphenhydramine Hcl Oral Solution |
Non-Proprietary Name | Diphenhydramine Hcl Oral |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20231215 |
Marketing Category Name | OTC MONOGRAPH DRUG |
Application Number | M009.50 |
Manufacturer | Rising Pharma Holdings, Inc. |
Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
Strength | 12.5 |
Strength Unit | mg/5mL |
Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |