Over-the-counter drug · NDA
Mucinex DM NDC 63824-056
guaifenesin and dextromethorphan hydrobromide · Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 · Tablet, Extended release · Oral · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63824-056-32 | 63824005632 | 1 BLISTER PACK in 1 CARTON (63824-056-32) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-056-34 | 63824005634 | 2 BLISTER PACK in 1 CARTON (63824-056-34) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-056-36 | 63824005636 | 1 BLISTER PACK in 1 CARTON (63824-056-36) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-056-69 | 63824005669 | 3 BLISTER PACK in 1 CARTON (63824-056-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 26, 2012 | |
| 63824-056-72 | 63824005672 | 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-72)Marketed from Jun 26, 2012 | |
| 63824-056-74 | 63824005674 | 24 POUCH in 1 CARTON (63824-056-74) / 2 TABLET, EXTENDED RELEASE in 1 POUCH (63824-056-73)Marketed from Jun 26, 2012 | |
| 63824-056-80 | 63824005680 | 2 BLISTER PACK in 1 CARTON (63824-056-80) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mucinex DM
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan hydrobromide
- Active ingredients
- Guaifenesin — 600 mg/1Dextromethorphan hydrobromide — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Reckitt Benckiser LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021620
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63824-056_544ce67c-9f6a-7f3e-e063-6294a90ad619SPL ID 544ce67c-9f6a-7f3e-e063-6294a90ad619SPL set ID 70987d06-d206-445f-bd0d-5e1345b8465cRxCUI 1298324UNII 495W7451VQ, 9D2RTI9KYHUPC 0363824056203
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463824005632followed by a unit qualifier and the quantityPackage 63824-0056-32. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021620
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mucinex DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Navajo Manufacturing Company Inc. | 67751-171 |
| Mucinex DMguaifenesin and dextromethorphan hydrobromide | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Select Consumer Group | 85237-1650 |
| Mucinex DM, TRAVEL BASIXguaifenesin and dextromethorphan hydrobromide | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Lil' Drug Store Products, Inc. | 66715-6424 |
| Mucinex DM, CVP HEALTHguaifenesin and dextromethorphan hydrobromide | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Lil' Drug Store Products, Inc. | 66715-6524 |
| Mucinex DMguaifenesin and dextromethorphan hydrobromide | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1077 |
| Mucinex DMguaifenesin and dextromethorphan hydrobromide | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1078 |
| Mucinex DM Maximum Strengthguaifenesin and dextromethorphan hydrobromide | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6549 |
| Mucinex DM Maximum Strengthguaifenesin and dextromethorphan hydrobromide | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Reckitt Benckiser LLC | 63824-072 |
| Mucinex DMguaifenesin and dextromethorphan hydrobromide | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-176 |
| Mucinex DMguaifenesin and dextromethorphan hydrobromide | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Lil' Drug Store Products, Inc. | 66715-9724 |