Search by Drug Name or NDC
NDC 53809-0201-01 DOMETUSS-DM 30; 200 mg/5mL; mg/5mL Details
DOMETUSS-DM 30; 200 mg/5mL; mg/5mL
DOMETUSS-DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Domel Laboratories. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
Product Information
| NDC | 53809-0201 |
|---|---|
| Product ID | 53809-201_ead5f038-87c6-4935-87e7-60e0f26658ec |
| Associated GPIs | |
| GCN Sequence Number | 024475 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 200-15MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53553 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | DOMETUSS-DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | GUAIFENESIN, DEXTROMETHORPHAN HBr |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 30; 200 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Domel Laboratories |
| Pharmaceutical Class | 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 Ant |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53809-0201-01 (53809020101)
| NDC Package Code | 53809-201-01 |
|---|---|
| Billing NDC | 53809020101 |
| Package | 30 mL in 1 BOTTLE (53809-201-01) |
| Marketing Start Date | 2016-01-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |