The short version
4 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.
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate · ACETAMINOPHEN 325 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 · Capsule, Liquid Filled · Oral · Softgel Healthcare Private Limited
NDC 35916-0154-01 · 1 BLISTER PACK in 1 CARTON / 12 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.
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 |
|---|---|---|---|
| Kenvue Brands LLC | DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Prodose, Inc. | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Softgel Healthcare Private Limited | ACETAMINOPHEN 325 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Softgel Healthcare Private Limited | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Kenvue Brands LLC | DEXTROMETHORPHAN HYDROBROMIDE 325 mg/1; DOXYLAMINE SUCCINATE 15 mg/1; ACETAMINOPHEN 6.25 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Softgel Healthcare Private Limited | ACETAMINOPHEN 325 mg/1; DOXYLAMINE SUCCINATE 15 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 6.25 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Kenvue Brands LLC | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Softgel Healthcare Private Limited | 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, "Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate — NDC 35916-0154-01," retrieved September 3, 2026, https://drugdashboards.com/drug/35916015401.
Free to cite with attribution — see how the data is put together.