Tusnel DM
- Product NDC
- 54859-603
- 11-digit product format
- 548590603
- Labeler code
- 54859
- Product ID
- 54859-603_47463023-1b8c-729b-e063-6394a90a8dce
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
- Dosage form
- SOLUTION/ DROPS
- Route
- ORAL
- Labeler
- Llorens Pharmaceutical International Division
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1993-01-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 2.5; 25; 7.5 mg/mL; mg/mL; mg/mL
- 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 DM
- Brand name suffix
- Pediatric
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 2.5 mg/mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 25 mg/mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 7.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 6V9V2RYJ8N, 9D2RTI9KYH |
| Rxcui | 1241674 |
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 |
|---|
| 54859-603-02 | Tusnel DMPediatric | 60 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 60 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54859-603 | TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241222_d915eab8-013e-4ce3-b358-0d531e5ca1ba.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 |
|---|
| 54859-603-02 | 54859060302 | 60 mL in 1 BOTTLE, DROPPER (54859-603-02) | 60 ml | 1993-01-01 | 0000-00-00 | No | No | Current |