Home NDC 69968-0539 Listerine Ultraclean Antiseptic
Product NDC 69968-0539
11-digit product format 699680539
Labeler code 69968
Product ID 69968-0539_22797442-320d-5c9c-e063-6394a90a20c8
Type HUMAN OTC DRUG
Nonproprietary name Eucalyptol, Menthol, unspecified form, Methyl Salicylate, and Thymol
Dosage form MOUTHWASH
Route ORAL
Labeler Kenvue Brands LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-06-01
Substance EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL
Active strength .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 EUCALYPTOL .92 mg/mL MENTHOL, UNSPECIFIED FORM .42 mg/mL METHYL SALICYLATE .6 mg/mL THYMOL .64 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 69968-0539-1 Listerine Ultraclean AntisepticCool Mint 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 10 69968-0539-2 Listerine Ultraclean AntisepticCool Mint 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 10 69968-0539-3 Listerine Ultraclean AntisepticCool Mint 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 10 69968-0539-4 Listerine Ultraclean AntisepticCool Mint 2 in 1 PACKAGE MOUTHWASH 2 10 69968-0539-5 Listerine Ultraclean AntisepticCool Mint 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0539 LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC] 10 Current NDC, Legacy NDC, 5 package rows 20241114_dd3729c2-fd05-4db0-a542-487bb0f9001f.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 Marketing end Sample Exclude flag Status 69968-0539-1 69968053901 1000 mL in 1 BOTTLE, PLASTIC (69968-0539-1) 1000 ml 2012-06-01 0000-00-00 No No Current 69968-0539-2 69968053902 250 mL in 1 BOTTLE, PLASTIC (69968-0539-2) 250 ml 2012-06-01 0000-00-00 No No Current 69968-0539-3 69968053903 1500 mL in 1 BOTTLE, PLASTIC (69968-0539-3) 1500 ml 2012-06-01 0000-00-00 No No Current 69968-0539-4 69968053904 2 BOTTLE, PLASTIC in 1 PACKAGE (69968-0539-4) / 1500 mL in 1 BOTTLE, PLASTIC (69968-0539-3) 2012-06-01 0000-00-00 No No Current 69968-0539-5 69968053905 500 mL in 1 BOTTLE, PLASTIC (69968-0539-5) 500 ml 2012-06-01 0000-00-00 No No Current