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 LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength 40; 10 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas When using this product ▪ avoid contact with eyes Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days ▪ symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 40 mg/g LIDOCAINE 10 mg/g
Harmonized Identifiers# Field, Values table Field Values Unii L7T10EIP3A, 98PI200987 Rxcui 250912
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
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