| NDC Code | 71309-110-10 |
| Package Description | 100 BOTTLE in 1 BOTTLE (71309-110-10) > 1000 BOTTLE in 1 BOTTLE (71309-110-01) > 500 BOTTLE in 1 BOTTLE (71309-110-05) > 30 CARTON in 1 BOTTLE (71309-110-30) > 1 TABLET, COATED in 1 CARTON |
| Product NDC | 71309-110 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Sleep-ez Nighttime Sleep Aid |
| Non-Proprietary Name | Diphenhydramine Hcl 25 Mg |
| Dosage Form | TABLET, COATED |
| Usage | ORAL |
| Start Marketing Date | 20170601 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Manufacturer | Safrel Pharmaceuticals, LLC. |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Strength | 25 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |