Home NDC 69968-0791 Listerine Cool Mint Antiseptic
Product NDC 69968-0791
11-digit product format 699680791
Labeler code 69968
Product ID 69968-0791_2f7de032-dffb-089c-e063-6394a90a673a
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Kenvue Brands LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-21
Substance METHYL SALICYLATE; THYMOL; EUCALYPTOL; MENTHOL
Active strength .6; .64; .92; .42 mg/mL; mg/mL; mg/mL; mg/mL
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 Listerine Cool Mint Antiseptic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE .6 mg/mL THYMOL .64 mg/mL EUCALYPTOL .92 mg/mL MENTHOL .42 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043619 Internal RxNorm lookup 1043623 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 69968-0791-1 Listerine Cool Mint Antiseptic 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 7 69968-0791-2 Listerine Cool Mint Antiseptic 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 7 69968-0791-3 Listerine Cool Mint Antiseptic 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 7 69968-0791-4 Listerine Cool Mint Antiseptic 3700 mL in 1 BOTTLE, PLASTIC MOUTHWASH 3700 7 69968-0791-5 Listerine Cool Mint Antiseptic 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 7 69968-0791-6 Listerine Cool Mint Antiseptic 2 in 1 PACKAGE MOUTHWASH 2 7 69968-0791-6 Listerine Cool Mint Antiseptic 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 7 69968-0791-9 Listerine Cool Mint Antiseptic 95 mL in 1 BOTTLE, PLASTIC MOUTHWASH 95 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0791 LISTERINE COOL MINT ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KENVUE BRANDS LLC] 7 Current NDC, 8 package rows 20250308_edb9e374-4dba-5823-e053-2a95a90a3da5.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 9 of 40 · 786 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 69968-0791-1 69968079101 1000 mL in 1 BOTTLE, PLASTIC (69968-0791-1) 1000 ml 2023-03-21 No No Current 69968-0791-2 69968079102 1500 mL in 1 BOTTLE, PLASTIC (69968-0791-2) 1500 ml 2023-03-21 No No Current 69968-0791-3 69968079103 250 mL in 1 BOTTLE, PLASTIC (69968-0791-3) 250 ml 2023-03-21 No No Current 69968-0791-4 69968079104 3700 mL in 1 BOTTLE, PLASTIC (69968-0791-4) 3700 ml 2023-03-21 No No Current 69968-0791-5 69968079105 500 mL in 1 BOTTLE, PLASTIC (69968-0791-5) 500 ml 2023-03-21 No No Current 69968-0791-6 69968079106 2 BOTTLE, PLASTIC in 1 PACKAGE (69968-0791-6) / 1500 mL in 1 BOTTLE, PLASTIC 2023-03-21 No No Current 69968-0791-9 69968079109 95 mL in 1 BOTTLE, PLASTIC (69968-0791-9) 95 ml 2023-03-21 No No Current