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 |
|---|---|---|---|---|---|---|
| infants fever reducer and pain reliever | ACETAMINOPHEN | Rite Aid Corporation | 920e7055-7ed1-4db4-9215-f8933078bb7b | 2026-07-24 | Warnings | M013 |
| Dye Free Pain and Fever Childrens | ACETAMINOPHEN | Walgreens | c6665c11-9a01-4472-a444-acadb1de0b69 | 2026-07-23 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 103d109d-f520-409c-8da2-eb6b0fbec891 | 2026-07-22 | Warnings | M013 |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | ce58105b-f010-47af-8f31-6dd4ce4e9cba | 2026-07-22 | Warnings | M013 |
| GOOD SENSE INFANTS PAIN AND FEVER | ACETAMINOPHEN | L. Perrigo Company | a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7 | 2026-07-22 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | 7562f4e4-54fa-488c-a199-48ad2632e2a1 | 2026-07-21 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | 4b1d7243-b943-4e2b-e063-6294a90a2c4e | 2026-07-20 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | LEADER/ Cardinal Health 110, Inc. | 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d | 2026-07-16 | Warnings | M013 |
| Rapidol 500 Extra Strength | ACETAMINOPHEN | Pharmadel LLC | 1d9fa7ec-a509-28b2-e063-6294a90a7831 | 2026-07-16 | Warnings | M013 |
| equate pain relief | ACETAMINOPHEN | WALMART INC. | 2f9b2550-5476-49ae-b741-54416a40bc29 | 2026-07-16 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | HyVee Inc | 4f45a750-1220-4a81-801e-bf08c9d117d6 | 2026-07-16 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Dr. Reddy's Laboratories Inc. | 9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f | 2026-07-15 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Family Dollar, Inc. | 3f182571-3212-eb29-e063-6294a90a9fa0 | 2026-07-15 | Warnings | M013 |
| Aspirin | ASPIRIN | DOLGENCORP, LLC | 955484a6-2a7a-4b15-a9b4-e888ed5de04c | 2026-07-15 | Warnings | M013 |
| Aspirin | ASPIRIN | Geri-Care Pharmaceuticals, Corp | 58941782-362d-4436-b365-e909bdbd29a2 | 2026-07-15 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Major Pharmaceuticals | 44730dfb-5062-4015-924b-c30b6c2b19c2 | 2026-07-13 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Cardinal Health 110, LLC. DBA Leader | f1cd0d59-12a8-4ff2-942a-6faa6907ef05 | 2026-07-13 | Warnings | M013 |
| Aspirin | ASPIRIN | Amerisource Bergen | 2c5e80e8-a979-45fb-9297-8ff294280c25 | 2026-07-13 | Warnings | M013 |
| INFANTS PAIN AND FEVER | ACETAMINOPHEN | Amazon.com Services LLC | 112076c4-cac2-45ab-9c77-5573edae7180 | 2026-07-10 | Warnings | M013 |
| Aspirin | ASPIRIN | Wal-Mart Stores Inc | 8ae16aa2-54bc-4c1a-aa36-93524199a67b | 2026-07-09 | 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 |