The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
SanaTos Severe Cold Relief Nighttime
Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride · DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg/1; ACETAMINOPHEN 650 mg/1 · Granule, For Solution · Oral · Pharmadel LLC
NDC 55758-0385-06 · 6 GRANULE, FOR SOLUTION in 1 CARTON · 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, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride (Granule, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Pharmadel LLC | DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg/1; ACETAMINOPHEN 650 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Pharmadel LLC | DIPHENHYDRAMINE HYDROCHLORIDE 650 mg/1; PHENYLEPHRINE HYDROCHLORIDE 25 mg/1; ACETAMINOPHEN 10 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Pharmadel LLC | ACETAMINOPHEN 650 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 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, "SanaTos Severe Cold Relief Nighttime — NDC 55758-0385-06," retrieved September 3, 2026, https://drugdashboards.com/drug/55758038506.
Free to cite with attribution — see how the data is put together.