Tylenol PM
- Product NDC
- 53209-1002
- 11-digit product format
- 532091002
- Labeler code
- 53209
- Product ID
- 53209-1002_37e8f74e-9c3f-b0e7-e063-6394a90a5106
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen and diphenhydramine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Morning Star OTC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-19
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 500; 25 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tylenol PM
- Brand name suffix
- Extra Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40 |
| Rxcui | 1092189, 1092378 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53209-1002-1 | Tylenol PMExtra Strength | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | | 1 |
| 53209-1002-2 | Tylenol PMExtra Strength | 25 in 1 POUCH | TABLET, FILM COATED | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53209-1002-1 | 53209100201 | 2 in 1 BLISTER PACK | | | | | Historical |
| 53209-1002-2 | 53209100202 | 25 BLISTER PACK in 1 POUCH (53209-1002-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1002-1) | 25 blister pack | 2025-06-19 | No | No | Historical |