NDC Code | 55758-385-06 |
Package Description | 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06) |
Product NDC | 55758-385 |
Product Type Name | HUMAN OTC DRUG |
Proprietary Name | Sanatos |
Proprietary Name Suffix | Severe Cold Relief Nighttime |
Non-Proprietary Name | Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride |
Dosage Form | GRANULE, FOR SOLUTION |
Usage | ORAL |
Start Marketing Date | 20240331 |
Marketing Category Name | OTC MONOGRAPH DRUG |
Application Number | M012 |
Manufacturer | Pharmadel LLC |
Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
Strength | 650; 25; 10 |
Strength Unit | mg/1; mg/1; mg/1 |
Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |