The short version
Only one company currently supplies this market — there is no backup if it stumbles.
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Acetaminophen , Caffeine and pyrilamine maleate
Acetaminophen , Caffeine and pyrilamine maleate · CAFFEINE 60 mg/1; PYRILAMINE MALEATE 15 mg/1; ACETAMINOPHEN 500 mg/1 · Capsule · Oral · Softgel Healthcare Pvt Ltd
NDC 35916-1234-01 · 1500 CAPSULE in 1 BAG · 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
- M013
- 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 , Caffeine and pyrilamine maleate (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Softgel Healthcare Pvt Ltd | CAFFEINE 60 mg/1; PYRILAMINE MALEATE 15 mg/1; ACETAMINOPHEN 500 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Softgel Healthcare Pvt Ltd | CAFFEINE 500 mg/1; PYRILAMINE MALEATE 60 mg/1; ACETAMINOPHEN 15 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Softgel Healthcare Pvt Ltd | ACETAMINOPHEN 500 mg/1; CAFFEINE 60 mg/1; PYRILAMINE MALEATE 15 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 , Caffeine and pyrilamine maleate — NDC 35916-1234-01," retrieved September 3, 2026, https://drugdashboards.com/drug/35916123401.
Free to cite with attribution — see how the data is put together.