Tusnel
- Product NDC
- 54859-544
- 11-digit product format
- 548590544
- Labeler code
- 54859
- Product ID
- 54859-544_47461ad3-a121-2a11-e063-6294a90a0f8f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Llorens Pharmaceutical International Division
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2006-01-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 5; 50; 15 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-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-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
- Tusnel
- Brand name suffix
- Pediatric
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| GUAIFENESIN | 50 mg/5mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 15 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1098911 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54859-544-04 | TusnelPediatric | 118 mL in 1 BOTTLE | LIQUID | 118 | | 9 |
| 54859-544-16 | TusnelPediatric | 473 mL in 1 BOTTLE | LIQUID | 473 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| CORN SYRUP | INACTIVE INGREDIENT | 9G5L16BK6N | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| POTASSIUM CITRATE | INACTIVE INGREDIENT | EE90ONI6FF | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54859-544 | TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241222_82f447f6-4f1b-4f56-9d7d-ea02adeea88c.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 |
|---|
| 54859-544-04 | 54859054404 | 118 mL in 1 BOTTLE (54859-544-04) | 118 ml | 2006-01-01 | 0000-00-00 | No | No | Current |
| 54859-544-16 | 54859054416 | 473 mL in 1 BOTTLE (54859-544-16) | 473 ml | 2006-01-01 | 0000-00-00 | No | No | Current |