Cold, Flu and Sore Throat
- Product NDC
- 50844-005
- Requested package NDC
- 50844-005-45
- 11-digit product format
- 508440005
- Labeler code
- 50844
- Product ID
- 50844-005_686b9f8a-79ba-4957-92da-d757b2e0ee99
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2017-03-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650 mg/20mL; mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-005 | COLD, FLU AND SORE THROAT MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [L.N.K. INTERNATIONAL, INC.] | 13 | Legacy NDC | 20250217_1876f1db-1a82-4692-8d29-a4b764064c80.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50844-005-45 | 50844000545 | 177 mL in 1 BOTTLE, PLASTIC (50844-005-45) | 177 ml | 2017-03-01 | 0000-00-00 | No | No | Current |