The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Cold and Flu severe
Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl · ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; GUAIFENESIN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 · Tablet, Film Coated · Oral · Wal-Mart Stores Inc
NDC 49035-0053-08 · 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK · 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.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (oral solid) in the next 90 days
price up 11% YoY · sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Opioid Analgesic REMS Shared System REMS
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 Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Wal-Mart Stores Inc | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; GUAIFENESIN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Cold and Flu severe — NDC 49035-0053-08," retrieved September 3, 2026, https://drugdashboards.com/drug/49035005308.
Free to cite with attribution — see how the data is put together.