| NDC Code | 73564-814-16 |
| Package Description | 1 BOTTLE in 1 BOX (73564-814-16) / 473 mL in 1 BOTTLE |
| Product NDC | 73564-814 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Diphenhydramine Oral Solution |
| Non-Proprietary Name | Diphenhydramine Kci12.5mg/5ml |
| Dosage Form | SOLUTION |
| Usage | ORAL |
| Start Marketing Date | 20260101 |
| Marketing Category Name | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Manufacturer | Aldama Pharmaceuticals, Inc |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Strength | 12.5 |
| Strength Unit | mg/5mL |
| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |