The short version
11 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Maximum Strength Nighttime Severe Cold and Flu
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride · ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 · Capsule, Liquid Filled · Oral · Prodose, Inc.
NDC 68210-4210-01 · 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED 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.
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 hydrochloride (Capsule, Liquid Filled)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bayer HealthCare LLC. | PHENYLEPHRINE HYDROCHLORIDE 5 mg/1; ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Catalent Ontario Limited | ACETAMINOPHEN 325 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Catalent Ontario Limited | DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; ACETAMINOPHEN 325 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| HyVee Inc | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Sep 3, 2026 | Sep 3, 2026 |
| Topco Associates LLC | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Bayer HealthCare LLC. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bayer HealthCare LLC. | DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; ACETAMINOPHEN 325 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Bioventure Healthcare - FZE | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Prodose, Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Retail Business Services, LLC | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Strive Pharmaceuticals Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Walmart Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Chain Drug Marketing Association, Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Bayer HealthCare LLC. | PHENYLEPHRINE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 10 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 6.25 mg/1; DOXYLAMINE SUCCINATE 5 mg/1 | Jul 22, 2026 | Aug 22, 2026 |
| Bayer HealthCare LLC. | DEXTROMETHORPHAN HYDROBROMIDE 325 mg/1; ACETAMINOPHEN 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Catalent Ontario Limited | ACETAMINOPHEN 325 mg/1; DOXYLAMINE SUCCINATE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Catalent Ontario Limited | DEXTROMETHORPHAN HYDROBROMIDE 325 mg/1; DOXYLAMINE SUCCINATE 10 mg/1; ACETAMINOPHEN 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Catalent Ontario Limited | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Jul 18, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Maximum Strength Nighttime Severe Cold and Flu — NDC 68210-4210-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68210421001.
Free to cite with attribution — see how the data is put together.