NDC product
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
NDC 35916-0188 · Softgel Healthcare Private Limited
Key facts
| Product NDC | 35916-0188 |
|---|---|
| Proprietary name | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg |
| Nonproprietary name | Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl |
| Substances | PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN |
| Dosage form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Labeler | Softgel Healthcare Private Limited |
| Product type | HUMAN OTC DRUG |
| Marketing category | OTC MONOGRAPH DRUG |
| Application number | M012 |
| Pharmacologic classes | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| Marketing start | Mar 21, 2025 |
| Listing certified through | Dec 31, 2027 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: