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.
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels
Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride · ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 · Capsule, Liquid Filled · Oral · Bayer HealthCare LLC.
NDC 00280-8276-16 · 2 BLISTER PACK in 1 CARTON / 8 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. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| PuraCap Pharmaceutical 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. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/1; DOXYLAMINE SUCCINATE 5 mg/1 | Jul 22, 2026 | Aug 22, 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 | Jul 18, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels — NDC 00280-8276-16," retrieved September 3, 2026, https://drugdashboards.com/drug/00280827616.
Free to cite with attribution — see how the data is put together.