| 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] |