Home NDC 69968-0788 Listerine Ultraclean Antiseptic
Product NDC 69968-0788
11-digit product format 699680788
Labeler code 69968
Product ID 69968-0788_322bfae8-c5a1-449b-e063-6294a90a596e
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 2023-02-05
Substance THYMOL; EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength .64; .92; .42; .6 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 Ultraclean Antiseptic
Brand name suffix Cool Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THYMOL .64 mg/mL EUCALYPTOL .92 mg/mL MENTHOL, UNSPECIFIED FORM .42 mg/mL METHYL SALICYLATE .6 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 2043303 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 69968-0788-1 Listerine Ultraclean AntisepticCool Mint 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 6 69968-0788-2 Listerine Ultraclean AntisepticCool Mint 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 6 69968-0788-5 Listerine Ultraclean AntisepticCool Mint 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 6 69968-0788-9 Listerine Ultraclean AntisepticCool Mint 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 6 69968-0788-9 Listerine Ultraclean AntisepticCool Mint 2 in 1 PACKAGE MOUTHWASH 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0788 LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KENVUE BRANDS LLC] 6 Current NDC, 5 package rows 20250413_ee467ec4-bd5e-644a-e053-2a95a90ac273.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 15 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 69968-0788-1 69968078801 1000 mL in 1 BOTTLE, PLASTIC (69968-0788-1) 1000 ml 2023-02-05 No No Current 69968-0788-2 69968078802 1500 mL in 1 BOTTLE, PLASTIC (69968-0788-2) 1500 ml 2023-02-05 No No Current 69968-0788-5 69968078805 500 mL in 1 BOTTLE, PLASTIC (69968-0788-5) 500 ml 2023-02-05 No No Current 69968-0788-9 69968078809 2 BOTTLE, PLASTIC in 1 PACKAGE (69968-0788-9) / 1500 mL in 1 BOTTLE, PLASTIC 2023-02-05 No No Current