The short version
8 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Tylenol PM Extra Strength
acetaminophen and diphenhydramine hydrochloride · ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 · Tablet, Film Coated · Oral · Morning Star OTC
NDC 53209-1002-02 · 25 BLISTER PACK in 1 POUCH / 2 TABLET, FILM COATED 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.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for acetaminophen and diphenhydramine hydrochloride (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
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 and diphenhydramine hydrochloride (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Lil' Drug Store Products, Inc. | DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1; ACETAMINOPHEN 500 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Apl Healthcare Limited | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Chattem, Inc. | ACETAMINOPHEN 325 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Kenvue Brands LLC | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lil' Drug Store Products, Inc. | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Morning Star OTC | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Navajo Manufacturing Company Inc. | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Prodose, Inc. | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Select Consumer Group | ACETAMINOPHEN 500 mg/1; DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lil' Drug Store Products, Inc. | DIPHENHYDRAMINE HYDROCHLORIDE 500 mg/1; ACETAMINOPHEN 25 mg/1 | Jul 22, 2026 | Aug 21, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Tylenol PM Extra Strength — NDC 53209-1002-02," retrieved September 3, 2026, https://drugdashboards.com/drug/53209100202.
Free to cite with attribution — see how the data is put together.