Home NDC 50580-833-01 TYLENOL PM
Product NDC 50580-833
Requested package NDC 50580-833-01
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.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 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 table Ingredient Strength ACETAMINOPHEN 1000 mg/30mL DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
FDA-Initiated Inactive NDC Indexing# 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.
Matched openFDA labels page 1 of 78 · 1,552 matching rows.
Packages# Package NDC, 11-digit format, Description table 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