Mucinex DM
- Product NDC
- 50090-1078
- 11-digit product format
- 500901078
- Labeler code
- 50090
- Product ID
- 50090-1078_2d8f9588-73e7-458f-b0e2-54787612b7a1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Dextromethorphan Hydrobromide
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA021620
- Marketing category
- NDA
- Marketing start
- 2012-06-26
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 30; 600 mg/1; mg/1
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mucinex DM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/1 |
| GUAIFENESIN | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1298324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-1078-0 | Mucinex DM | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 12 |
| 50090-1078-0 | Mucinex DM | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1078 | MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240112_c04e67da-51f6-4ce3-9852-419d7b3a3742.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 |
|---|
| 50090-1078-0 | 50090107800 | 2 BLISTER PACK in 1 CARTON (50090-1078-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2014-11-28 | 0000-00-00 | No | No | Current |