NDC product
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
NDC 35916-0189 · SOFTGEL HEALTHCARE PRIVATE LIMITED
Key facts
| Product NDC | 35916-0189 |
|---|---|
| Proprietary name | Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate |
| Nonproprietary name | Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate |
| Substances | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE |
| 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 | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| Marketing start | Apr 4, 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: