The short version
Only one company currently supplies this market — there is no backup if it stumbles.
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Tussnex FM Cold, Flu and Sore Throat
Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · ACETAMINOPHEN 650 mg/20mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL; GUAIFENESIN 400 mg/20mL; PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL · Liquid · Oral · Guardian Drug Company
NDC 53041-0618-58 · 177 mL in 1 CARTON · OTC MONOGRAPH DRUG · View full market →
Medicare Part D
Medicare Part D does not cover over-the-counter drugs — by law it pays only for products requiring a prescription.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Regulatory
- Application
- M012
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl (Liquid)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Guardian Drug Company | ACETAMINOPHEN 325 mg/10mL; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL; PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL; GUAIFENESIN 200 mg/10mL | Aug 26, 2026 | Sep 2, 2026 |
| Guardian Drug Company | ACETAMINOPHEN 650 mg/20mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL; GUAIFENESIN 400 mg/20mL; PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL | Jul 15, 2026 | Sep 2, 2026 |
| Guardian Drug Company | ACETAMINOPHEN 325 mg/10mL; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL; PHENYLEPHRINE HYDROCHLORIDE 200 mg/10mL; GUAIFENESIN 5 mg/10mL | Jul 22, 2026 | Aug 19, 2026 |
| Guardian Drug Company | ACETAMINOPHEN 325 mg/10mL; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL; GUAIFENESIN 200 mg/10mL; PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Tussnex FM Cold, Flu and Sore Throat — NDC 53041-0618-58," retrieved September 3, 2026, https://drugdashboards.com/drug/53041061858.
Free to cite with attribution — see how the data is put together.