TYLENOL PM
- Product NDC
- 50580-833
- 11-digit product format
- 505800833
- Labeler code
- 50580
- Product ID
- 50580-833_5def488c-5857-81d7-e063-6294a90ac270
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Diphenhydramine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-06-25
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 1000; 50 mg/30mL; mg/30mL
- 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50580-833-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50580-833-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50580-833-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50580-833-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50580-833-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50580-833-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50580-833-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50580-833-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50580-833-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50580-833-01 | ad56d346431e… | cc804d4bbf1e… |
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 | 1000 mg/30mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/30mL |
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 |
|---|---|
| 44e8a92a-748b-4dc3-ae8d-176a350ac83d | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-02-01 | TYLENOL PM Extra Strength |
| 2024-02-01 | TYLENOL PM Extra Strength |
| 2024-01-30 | TYLENOL PM Extra Strength |
| 2024-01-30 | TYLENOL PM Extra Strength |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-833-01 | ML - Milliliter | 50580-833 | 4eb50548-bfd6-4ca0-8b96-8e53a76d98be | 1 | 2018-10-11 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Meijer Distribution Inc | 4e08a7cb-3894-84c3-e063-6394a90a0b42 | 2026-06-30 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Wal-Mart Stores Inc | 9b1201af-c802-4e19-b192-bbbf34367db4 | 2026-06-30 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | P & L Development, LLC | fc841cba-8f4f-407b-97de-0422977515bd | 2026-06-30 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | United Natural Foods, Inc. dba UNFI | b6ff2b34-51ee-41bc-8b7d-7520ade0bf36 | 2026-06-30 | Warnings | M013 |
| Medline | ASPIRIN | Medline Industries, LP | 4b0c569a-ed7a-e104-e063-6394a90a6d54 | 2026-06-29 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | e50b3f60-b827-426c-8e78-8447c89130fe | 2026-06-29 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Chain Drug Marketing Association, Inc. | e58417f4-3575-4433-ac2e-b7bf9fe8ba10 | 2026-06-29 | Warnings | M013 |
| Dr Kids Pain and Fever | ACETAMINOPHEN | CalmCo LLC | 5534a784-a7b1-5599-e063-6294a90a7961 | 2026-06-27 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Select Consumer Group LLC | 529d3a51-a248-7c02-e063-6294a90a10ae | 2026-06-27 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Sportpharm LLC | 830ffcaa-7ff8-4732-bc84-6a8c5e78722d | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Strategic Sourcing Services LLC | ea2ef485-429e-4c63-ba7b-0a6b32892ad2 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Chain Drug Marketing Association, Inc. | 055d8420-c189-4a9e-acdc-21627935c8eb | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Topco Associates, LLC | 5f32cf74-dbea-496c-ba23-2040ea354f40 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Salado Sales, Inc. | cf3139a5-e36e-48e3-bb6c-e102b0cec555 | 2026-06-25 | Warnings | M013 |
| Pain Relief Aspirin | ASPIRIN | Rite Aid Corporation | bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 | 2026-06-25 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | Walgreen Company | 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef | 2026-06-25 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | ARMY AND AIR FORCE EXCHANGE SERVICE | e273ead7-7cbc-4fd5-a136-9d3558a35360 | 2026-06-24 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | CVS PHARMACY | 5e35df92-6282-4ca6-902b-bb6bd326b487 | 2026-06-23 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Orelli Inc. | 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d | 2026-06-22 | Warnings | M013 |
| Pain Relief Aspirin Chewable, Low Dose | ASPIRIN | Rite Aid Corporation | 65cdce0f-be04-43ba-8c68-bdce7983cfa1 | 2026-06-22 | Warnings | M013 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-833-01 | 50580083301 | 240 mL in 1 BOTTLE (50580-833-01) | 240 ml | 2018-06-25 | 0000-00-00 | No | No | Current |