Tylenol PM
- Product NDC
- 85237-2945
- 11-digit product format
- 852372945
- Labeler code
- 85237
- Product ID
- 85237-2945_55d0dd09-882d-754a-e063-6294a90a15ee
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen and diphenhydramine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Select Consumer Group
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-07-11
- 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
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tylenol PM
- Brand name suffix
- Extra Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55d0dceb-c9a9-778e-e063-6294a90a2ad7 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Aspirin Low Dose | ASPIRIN | ATLANTIC BIOLOGICALS CORP. | 024c5054-959f-4ea5-a71f-c0e16cc4b90c | 2025-06-24 | Warnings | M013 |
| CHILDRENS ACETAMINOPHEN | CHILDRENS ACETAMINOPHEN ORAL | AARNA USA INC. | 38070d15-2678-4e59-e063-6294a90ab690 | 2025-06-20 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Morning Star OTC | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 2025-06-19 | Warnings | M013 |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Morning Star OTC | 6cd07a01-7034-4994-bbd3-bedcdf7d5b83 | 2025-06-19 | Warnings | M013 |
| DRX CHOICE Tension Headache | ACETAMINOPHEN, CAFFEINE | Raritan Pharmaceuticals Inc. | 8a5cb38b-669d-4177-b33b-d73c7ef48d18 | 2025-06-13 | Warnings | M013 |
| good sense childrens pain and fever | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 3777f4fb-d279-199d-e063-6394a90acf36 | 2025-06-13 | Warnings | M013 |
| Aspirina Cafeina | ASPIRIN,CAFFEINE | Bayer HealthCare LLC. | 2e709acc-325a-baca-e063-6394a90a24be | 2025-06-12 | Warnings | M013 |
| Aspirin | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 696f55b1-536c-40c4-91f7-b572c39220db | 2025-06-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CVS Pharmacy, Inc. | 6dea9e11-ff99-63c7-e053-2a91aa0a5b54 | 2025-06-10 | Warnings | M013 |
| Children Acetaminophen Oral Solution | ACETAMINOPHEN | MAJOR PHARMACEUTICALS | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 2025-06-09 | Warnings | M013 |
| Aspirin | ASPIRIN | Trifecta Pharmaceuticals USA LLC | 372be427-acbd-c10c-e063-6294a90a572d | 2025-06-09 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS Pharmacy | d6c8118c-bf78-4194-9b14-8de33c3ecdb7 | 2025-06-06 | Warnings | M013 |
| Dolo-NeuroBion | ACETAMINOPHEN | BENARD INDUSTRIES INC | b8310770-84d1-4a6f-8e23-9974947f92f1 | 2025-06-04 | Warnings | M013 |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | Rite Aid Corporation | 69bda7d7-8660-4e8d-b8ac-892a3b1f2124 | 2025-06-03 | Warnings | M013 |
| Kids Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | fb74e8f9-d72f-4681-90bd-df48364405b5 | 2025-06-01 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | P & L Development, LLC | b815fcae-8bba-4737-ac10-29a32fb69275 | 2025-05-30 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | 81cc4900-226b-4c49-ba9c-5747d2a501b1 | 2025-05-29 | Warnings | M013 |
| good sense pain relief pm extra strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | e08a7ab1-4b68-422a-97bd-2c5326633943 | 2025-05-29 | Warnings | M013 |
| Acetaminophen Gelcaps | ACETAMINOPHEN | Kroger | 30d3f2d0-da35-7f6f-e063-6294a90a9c22 | 2025-05-23 | Warnings | M013 |
| Kids Pain and Fever | ACETAMINOPHEN | Genexa Inc. | fcffa7e6-145c-6bc0-e053-6294a90a4751 | 2025-05-23 | Warnings | M013 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-2945-1 | 85237294501 | 1 POUCH in 1 BLISTER PACK (85237-2945-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) | 1 pouch | 2022-06-01 | No | No | Current |
| 85237-2945-2 | 85237294502 | 2 POUCH in 1 BLISTER PACK (85237-2945-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) | 2 pouch | 2022-06-01 | No | No | Current |
| 85237-2945-3 | 85237294503 | 20 POUCH in 1 CONTAINER (85237-2945-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) | 20 pouch | 2022-06-01 | No | No | Current |
| 85237-2945-4 | 85237294504 | 25 POUCH in 1 CONTAINER (85237-2945-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) | 25 pouch | 2022-06-01 | No | No | Current |
| 85237-2945-6 | 85237294506 | 50 POUCH in 1 CONTAINER (85237-2945-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) | 50 pouch | 2022-06-01 | No | No | Current |
| 85237-2945-7 | 85237294507 | 3 POUCH in 1 BLISTER PACK (85237-2945-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) | 3 pouch | 2022-06-01 | No | No | Current |