DOMETUSS-DM
- Product NDC
- 53809-201
- 11-digit product format
- 538090201
- Labeler code
- 53809
- Product ID
- 53809-201_02354652-4696-45cc-94d0-d82092b0de8b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN, DEXTROMETHORPHAN HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Domel Laboratories
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-01-21
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 30; 200 mg/5mL; mg/5mL
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOMETUSS-DM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
| GUAIFENESIN | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1147924 |
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 |
|---|
| 53809-201-01 | DOMETUSS-DM | 30 mL in 1 BOTTLE | LIQUID | 30 | | 4 |
| 53809-201-04 | DOMETUSS-DM | 118 mL in 1 BOTTLE | LIQUID | 118 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53809-201 | DOMETUSS-DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DOMEL LABORATORIES] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250522_7c4e7eca-0dc2-4b49-bda5-d61770ef9aca.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 |
|---|
| 53809-201-01 | 53809020101 | 30 mL in 1 BOTTLE (53809-201-01) | 30 ml | 2016-01-21 | 0000-00-00 | No | No | Current |
| 53809-201-04 | 53809020104 | 118 mL in 1 BOTTLE (53809-201-04) | 118 ml | 2016-01-21 | 0000-00-00 | No | No | Current |