The short version
7 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Nighttime Cold And Flu Relief
Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate · DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; ACETAMINOPHEN 325 mg/1 · Capsule, Liquid Filled · Oral · Advanced Rx LLC
NDC 80513-0304-50 · 50 CAPSULE, LIQUID FILLED in 1 BOTTLE · 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 (oral solid) in the next 90 days
sole-source market · price up 1% YoY
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 Hydrobromide, and Doxylamine Succinate (Capsule, Liquid Filled)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Lil' Drug Store Products, Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Advanced Rx LLC | DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Haleon US Holdings LLC | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Patheon Softgels Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Raritan Pharmaceuticals Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| The Procter & Gamble Manufacturing Company | DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Walgreen Company | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Advanced Rx LLC | DEXTROMETHORPHAN HYDROBROMIDE 325 mg/1; DOXYLAMINE SUCCINATE 15 mg/1; ACETAMINOPHEN 6.25 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| The Procter & Gamble Manufacturing Company | DEXTROMETHORPHAN HYDROBROMIDE 325 mg/1; DOXYLAMINE SUCCINATE 15 mg/1; ACETAMINOPHEN 6.25 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Advanced Rx LLC | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| The Procter & Gamble Manufacturing Company | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Nighttime Cold And Flu Relief — NDC 80513-0304-50," retrieved September 3, 2026, https://drugdashboards.com/drug/80513030450.
Free to cite with attribution — see how the data is put together.