Home NDC 69968-0793 Tylenol Precise Cooling Pain Relieving
Product NDC 69968-0793
11-digit product format 699680793
Labeler code 69968
Product ID 69968-0793_4aeeae88-3c06-e83e-e063-6294a90aab70
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine, Menthol
Dosage form CREAM
Route TOPICAL
Labeler Kenvue Brands LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-03
Substance MENTHOL, UNSPECIFIED FORM; LIDOCAINE
Active strength 10; 40 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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.
Additional Listing Data#
Finished product Yes
Brand name base Tylenol Precise Cooling Pain Relieving
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 10 mg/g LIDOCAINE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 69968-0793-1 Tylenol Precise Cooling Pain Relieving 14.2 g in 1 TUBE CREAM 14.2 5 69968-0793-1 Tylenol Precise Cooling Pain Relieving 1 in 1 CARTON CREAM 1 5 69968-0793-2 Tylenol Precise Cooling Pain Relieving 1 in 1 CARTON CREAM 1 5 69968-0793-2 Tylenol Precise Cooling Pain Relieving 70 g in 1 TUBE CREAM 70 5 69968-0793-4 Tylenol Precise Cooling Pain Relieving 113 g in 1 TUBE CREAM 113 5 69968-0793-4 Tylenol Precise Cooling Pain Relieving 1 in 1 CARTON CREAM 1 5 69968-0793-9 Tylenol Precise Cooling Pain Relieving 113 g in 1 TUBE CREAM 113 5 69968-0793-9 Tylenol Precise Cooling Pain Relieving 2 in 1 CARTON CREAM 2 5 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 69968-0793 TYLENOL PRECISE COOLING PAIN RELIEVING (LIDOCAINE, MENTHOL) CREAM [KENVUE BRANDS LLC] 4 Current NDC, 8 package rows 20250303_fc0a3404-b174-3952-e053-6294a90a1e02.zip 69968-0793 TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC] 1 Current NDC 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 18 of 153 · 3,057 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 69968-0793-1 69968079301 1 TUBE in 1 CARTON (69968-0793-1) / 14.2 g in 1 TUBE 1 tube 2023-07-03 No No Current 69968-0793-2 69968079302 1 TUBE in 1 CARTON (69968-0793-2) / 70 g in 1 TUBE 1 tube 2025-11-30 No No Current 69968-0793-4 69968079304 1 TUBE in 1 CARTON (69968-0793-4) / 113 g in 1 TUBE 1 tube 2023-07-03 No No Current 69968-0793-9 69968079309 2 TUBE in 1 CARTON (69968-0793-9) / 113 g in 1 TUBE 2 tube 2024-03-01 No No Current