The short version
Just 2 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.
Severe cold and flu Nighttime
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI · ACETAMINOPHEN 650 mg/30mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL; DOXYLAMINE SUCCINATE 12.5 mg/30mL; PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL · Liquid · Oral · P & L Development, LLC
NDC 49580-0416-08 · 237 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.
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 Hydrobromide, Doxylamine Succinate, Phenylephrine HCI (Liquid)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| P & L Development, LLC | ACETAMINOPHEN 650 mg/30mL; DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL; DOXYLAMINE SUCCINATE 12.5 mg/30mL; PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL | Jul 15, 2026 | Sep 3, 2026 |
| Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 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 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Severe cold and flu Nighttime — NDC 49580-0416-08," retrieved September 3, 2026, https://drugdashboards.com/drug/49580041608.
Free to cite with attribution — see how the data is put together.