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.
Daytime Cold And Flu Relief Softgels Non-Drowsy
Acetaminophen, Dextromethorphan Hbr, Phenylephrine · DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 5 mg/1; ACETAMINOPHEN 325 mg/1 · Capsule, Gelatin Coated · Oral · Advanced Rx LLC
NDC 80513-0301-50 · 50 CAPSULE, GELATIN COATED 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.
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 Hbr, Phenylephrine (Capsule, Gelatin Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Advanced Rx LLC | DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 5 mg/1; ACETAMINOPHEN 325 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Advanced Rx LLC | DEXTROMETHORPHAN HYDROBROMIDE 325 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 10 mg/1; ACETAMINOPHEN 5 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Advanced Rx LLC | ACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 5 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, "Daytime Cold And Flu Relief Softgels Non-Drowsy — NDC 80513-0301-50," retrieved September 3, 2026, https://drugdashboards.com/drug/80513030150.
Free to cite with attribution — see how the data is put together.