Home NDC 50580-142 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
Product NDC 50580-142
11-digit product format 505800142
Labeler code 50580
Product ID 50580-142_2611d7e2-4446-b6b6-e063-6394a90a6232
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Lidocaine, Menthol
Dosage form KIT
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-25
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Extra Strength / TYLENOL Precise Cooling Pain Relief
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 209459 Internal RxNorm lookup 250912 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-142-01 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief 1 in 1 KIT KIT 1 1 50580-490-25 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief 225 in 1 BOTTLE TABLET, COATED 225 500 mg 1 50580-490-25 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief 1 in 1 CARTON TABLET, COATED 500 mg 1 69968-0793-1 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief 1 in 1 CARTON CREAM 40 mg in 1g 1 69968-0793-1 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief 14.2 g in 1 TUBE CREAM 14.2 g 40 mg in 1g 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-142 TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC] 1 Current NDC, 5 package rows 20241204_2611e984-0dd5-bda1-e063-6394a90a559a.zip
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 2 of 83 · 1,657 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 50580-142-01 50580014201 1 KIT in 1 KIT (50580-142-01) * 1 BOTTLE in 1 CARTON (50580-490-25) / 225 TABLET, COATED in 1 BOTTLE * 1 TUBE in 1 CARTON (69968-0793-1) / 14.2 g in 1 TUBE 1 kit 2024-11-25 No No Current 50580-490-25 50580049025 225 in 1 BOTTLE Historical 69968-0793-1 69968079301 1 in 1 CARTON Historical