Rugby Mucus Relief DM ER
- Product NDC
- 0536-1446
- 11-digit product format
- 005361446
- Labeler code
- 0536
- Product ID
- 0536-1446_85c51626-6e2f-4117-a2e0-1e5111a43422
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- ANDA207602
- Marketing category
- ANDA
- Marketing start
- 2025-04-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9D2RTI9KYH | DEXTROMETHORPHAN HYDROBROMIDE | 6700-34-1 | DEXTROMETHORPHAN HYDROBROMIDE |
| 495W7451VQ | GUAIFENESIN | 93-14-1 | GUAIFENESIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0536-1446-34 | 00536144634 | 1 BOTTLE in 1 CARTON (0536-1446-34) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2025-04-02 | No | No | Historical |