The short version
Only one company currently supplies this market — there is no backup if it stumbles.
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Broncochem Cold And Flu Tea
Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate · ACETAMINOPHEN 500 mg/13g; CHLORPHENIRAMINE MALEATE 4 mg/13g · Granule, For Solution · Oral · Laboratorio Magnachem International Srl
NDC 65131-0097-12 · 25 PACKAGE in 1 BOX / 13 g in 1 PACKAGE · 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
- M
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · OngoingFeb 16, 2024Global Corporation — Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Manufacturers of Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate (Granule, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Laboratorio Magnachem International Srl | ACETAMINOPHEN 500 mg/13g; CHLORPHENIRAMINE MALEATE 4 mg/13g | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Broncochem Cold And Flu Tea — NDC 65131-0097-12," retrieved September 3, 2026, https://drugdashboards.com/drug/65131009712.
Free to cite with attribution — see how the data is put together.