Over-the-counter drug · NDA
Mucinex 12HR Cold and Fever Multi-Symptom NDC 72854-001
naproxen sodium, dextromethorphan hydrobromide, guaifenesin · Dextromethorphan hydrobromide 30 mg/1 + 2 more ingredients · Tablet, Extended release · Oral · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72854-001-16 | 7285400011672854000116 | 2 BLISTER PACK in 1 CARTON (72854-001-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2026 | |
| 72854-001-32 | 7285400013272854000132 | 4 BLISTER PACK in 1 CARTON (72854-001-32) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2026 | |
| 72854-001-50 | 7285400015072854000150 | 5 BLISTER PACK in 1 CARTON (72854-001-50) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2026 |
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 12HR Cold and Fever Multi-SymptomSuffix: 12HR Cold and Fever Multi-Symptom
- Generic name (nonproprietary)
- naproxen sodium, dextromethorphan hydrobromide, guaifenesin
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/1Naproxen sodium — 110 mg/1Guaifenesin — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Reckitt Benckiser LLCNDC labeler code 72854
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217338
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72854-001_53490589-6b93-42b2-e063-6394a90a3c02SPL ID 53490589-6b93-42b2-e063-6394a90a3c02SPL set ID 49f1f415-8017-0974-e063-6294a90a8918RxCUI 2744506UNII 9D2RTI9KYH, 9TN87S3A3C, 495W7451VQ
- Pharmacologic class
- Expectorant; Nonsteroidal Anti-inflammatory Drug; 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
N472854000116followed by a unit qualifier and the quantityPackage 72854-0001-16. 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 ■ minor aches and pains due to headache and the common cold ■ temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 72854-001
- What is NDC 72854-001?
- 72854-001 is the product NDC for Mucinex 12HR Cold and Fever Multi-Symptom, Dextromethorphan hydrobromide 30 mg/1 + 2 more ingredients tablet, extended release, listed with the FDA by Reckitt Benckiser LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucinex 12HR Cold and Fever Multi-Symptom (Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Naproxen sodium, Guaifenesin.
- Who is the labeler?
- Reckitt Benckiser LLC, NDC labeler code 72854. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mucinex 12HR Cold and Fever Multi-Symptom?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.