Severe Congestion and Cough Relief
- Product NDC
- 50844-004
- 11-digit product format
- 508440004
- Labeler code
- 50844
- Product ID
- 50844-004_d2fb4630-827d-4478-b2c7-4f9820e6863f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-03-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 20; 400; 10 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Severe Congestion and Cough Relief
- Brand name suffix
- Maximum Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1043543 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50844-004-45 | Severe Congestion and Cough ReliefMaximum Strength | 177 mL in 1 BOTTLE | SOLUTION | 177 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-004 | SEVERE CONGESTION AND COUGH RELIEF MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [L.N.K. INTERNATIONAL, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20240828_8141ddc5-2a25-4800-a465-58d3b45bceb0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50844-004-45 | 50844000445 | 177 mL in 1 BOTTLE (50844-004-45) | 177 ml | 2017-03-01 | 0000-00-00 | No | No | Current |