The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
CVS NightTime Cold
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride · ACETAMINOPHEN 650 mg/30mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL; DOXYLAMINE SUCCINATE 12.5 mg/30mL; PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL · Solution · Oral · Cvs Pharmacy
NDC 51316-0641-12 · 354 mL in 1 BOTTLE, PLASTIC · 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 hydrobromide, doxylamine succinate, phenylephrine hydrochloride (other) in the next 90 days
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
- M010
- 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 hydrobromide, doxylamine succinate, and phenylephrine hydrochloride (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Cvs Pharmacy | ACETAMINOPHEN 650 mg/30mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL; DOXYLAMINE SUCCINATE 12.5 mg/30mL; PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL | Jul 15, 2026 | Sep 2, 2026 |
| Kenvue Brands LLC | ACETAMINOPHEN 325 mg/15mL; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL; DOXYLAMINE SUCCINATE 6.25 mg/15mL; PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL | Jul 15, 2026 | Sep 2, 2026 |
| The Procter & Gamble Manufacturing Company | ACETAMINOPHEN 650 mg/30mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL; DOXYLAMINE SUCCINATE 12.5 mg/30mL; PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL | Jul 15, 2026 | Sep 2, 2026 |
| The Procter & Gamble Manufacturing Company | PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL; DOXYLAMINE SUCCINATE 12.5 mg/30mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL; ACETAMINOPHEN 650 mg/30mL | Aug 26, 2026 | Aug 31, 2026 |
| The Procter & Gamble Manufacturing Company | PHENYLEPHRINE HYDROCHLORIDE 650 mg/30mL; DOXYLAMINE SUCCINATE 20 mg/30mL; DEXTROMETHORPHAN HYDROBROMIDE 12.5 mg/30mL; ACETAMINOPHEN 10 mg/30mL | Jul 22, 2026 | Aug 19, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "CVS NightTime Cold — NDC 51316-0641-12," retrieved September 3, 2026, https://drugdashboards.com/drug/51316064112.
Free to cite with attribution — see how the data is put together.