| Product ID | 68210-4226_ed867be1-86d9-0664-e053-2995a90abdb4 |
| NDC | 68210-4226 |
| Product Type | Human Otc Drug |
| Proprietary Name | Pain Reliever and Sleep Aid |
| Generic Name | Acetaminophen, And Diphenhydramine Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-11-15 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / |
| Application Number | part343 |
| Labeler Name | Spirit Pharmaceuticals LLC |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE |
| Active Ingredient Strength | 500 mg/1; mg/1 |
| Pharm Classes | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |