Home NDC 50269-552 Tylenol PM
Product NDC 50269-552
11-digit product format 502690552
Labeler code 50269
Product ID 50269-552_47bb04a2-2d89-ea44-e063-6294a90a1986
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler JC World Bell Wholesale Co., Inc.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50269-552-01 Tylenol PM 2 in 1 POUCH TABLET, FILM COATED 2 2 50269-552-01 Tylenol PM 20 in 1 BOX TABLET, FILM COATED 20 2
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 84 · 1,663 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50269-552-01 50269055201 20 POUCH in 1 BOX (50269-552-01) / 2 TABLET, FILM COATED in 1 POUCH 20 pouch 2016-07-11 No No Historical