The short version
Just 3 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.
Cold Medicine XL3 FORTE
Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride · ACETAMINOPHEN 325 mg/1; CHLORPHENIRAMINE MALEATE 4 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 · Tablet · Oral · Selder, S.A. de C.V.
NDC 63654-0601-10 · 1 BLISTER PACK in 1 BOX / 10 TABLET 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 Chlorpheniramine Maleate Phenylepherine Hydrochloride (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Midway Importing Inc. | ACETAMINOPHEN 325 mg/1; CHLORPHENIRAMINE MALEATE 4 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Midway Importing, Inc. | ACETAMINOPHEN 325 mg/1; CHLORPHENIRAMINE MALEATE 2 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Selder, S.A. de C.V. | ACETAMINOPHEN 325 mg/1; CHLORPHENIRAMINE MALEATE 2 mg/1; PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Selder, S.A. de C.V. | ACETAMINOPHEN 325 mg/1; CHLORPHENIRAMINE MALEATE 4 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Cold Medicine XL3 FORTE — NDC 63654-0601-10," retrieved September 3, 2026, https://drugdashboards.com/drug/63654060110.
Free to cite with attribution — see how the data is put together.