Safetussin
- Product NDC
- 0295-1111
- Requested package NDC
- 0295-1111-17
- 11-digit product format
- 002951111
- Labeler code
- 0295
- Product ID
- 0295-1111_ec942206-ebdb-6918-e053-2995a90a8499
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorpan Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Denison Pharmaceuticals, LLC.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2017-01-01
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10 mg/5mL; mg/5mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0295-1111-17 | 00295111117 | 120 mL in 1 BOTTLE (0295-1111-17) | 120 ml | 2017-01-01 | 0000-00-00 | No | No | Current |