Cold and Flu
- Product NDC
- 50844-763
- 11-digit product format
- 508440763
- Labeler code
- 50844
- Product ID
- 50844-763_04cb715e-0716-4c82-940d-59e3907b01ec
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Triprolidine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-05-03
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
- Active strength
- 650 mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- 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 |
|---|---|---|---|---|---|---|---|---|
| 50844-763-45 | 50844076345 | 177 mL in 1 BOTTLE, PLASTIC (50844-763-45) | 177 ml | 2022-05-03 | 0000-00-00 | No | No | Current |