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 |
|---|---|---|---|---|---|---|
| Aspirin Regimen | ASPIRIN | Cardinal Health 110, LLC. DBA Leader | 88f425df-712d-4911-824b-94085c7190b6 | 2026-06-19 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Meijer Distribution, Inc. | 3716a7d4-a555-4e54-aa0a-7b8f3e32addb | 2026-06-19 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DOLGENCORP, LLC | acc94a3e-21b6-4375-9881-38cf9bab8692 | 2026-06-19 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | L.N.K. International, Inc. | 2f6ec676-3832-420e-be91-fce83f6586c8 | 2026-06-19 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | DOLGENCORP, LLC | e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 | 2026-06-18 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Oncor Pharmaceuticals | 4c396d0e-aa93-4f9e-b065-2e606f7f05cd | 2026-06-17 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Famora Inc. | 4dc6f119-bbde-db5f-e063-6294a90a9486 | 2026-06-16 | Warnings | M013 |
| Childrens Pain and Fever Relief | ACETAMINOPHEN | Chain Drug Marketing Association, Inc. | 420a1e05-caa6-481f-bdab-a670f0220f96 | 2026-06-16 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DOLGENCORP, LLC | ce9f4e0d-43fb-499a-b8a2-a997a14841c4 | 2026-06-16 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | L.N.K. International, Inc. | 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 | 2026-06-15 | Warnings | M013 |
| RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 2d63671d-cf7c-bbdd-e063-6294a90affef | 2026-06-15 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 59773893-09a8-47a2-943a-e9ea9da4458a | 2026-06-15 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | Shield Pharmaceuticals Corp. | 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 | 2026-06-15 | Warnings | M013 |
| Duralgina Extra Strength | ACETAMINOPHEN | Menper Distributors, Inc. | 544e3d7e-a759-384f-e063-6294a90a5baa | 2026-06-15 | Warnings | M013 |
| pain relief childrens | ACETAMINOPHEN | Rite Aid Corporation | be2286a1-946b-4bf5-b14c-8e86da669594 | 2026-06-15 | Warnings | M013 |
| Aspirin 81 | ASPIRIN | Amerisource Bergen | 4491faca-f30b-4eb0-bea9-f518f6b2f095 | 2026-06-15 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | 55e996cd-ef22-4e09-a05c-8aa994e4540b | 2026-06-12 | Warnings | M013 |
| CHILDRENS TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 3162733b-9382-39f1-e063-6294a90ac420 | 2026-06-12 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Dr. Reddy's Laboratories Inc. | 9769e0c0-2f4c-3b7a-1a65-c98fbce11681 | 2026-06-12 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 54010ddf-25d1-2016-e063-6294a90a877d | 2026-06-11 | 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 |