Home NDC 69968-0400 LISTERINE
Product NDC 69968-0400
11-digit product format 699680400
Labeler code 69968
Product ID 69968-0400_2f2db917-d08b-0560-e063-6394a90aba42
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 2019-01-06
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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
Brand name suffix Original Antiseptic
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 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 69968-0400-1 LISTERINEOriginal Antiseptic 1500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1500 11 69968-0400-2 LISTERINEOriginal Antiseptic 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 11 69968-0400-3 LISTERINEOriginal Antiseptic 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 11 69968-0400-5 LISTERINEOriginal Antiseptic 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 11 69968-0400-8 LISTERINEOriginal Antiseptic 2 in 1 PACKAGE MOUTHWASH 2 11 69968-0400-9 LISTERINEOriginal Antiseptic 95 mL in 1 BOTTLE, PLASTIC MOUTHWASH 95 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0400 LISTERINE ORIGINAL ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC] 11 Current NDC, Legacy NDC, 6 package rows 20250308_78e2e172-09a4-4bf1-9871-d099c49087be.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 20 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Mouth Sore Relief BENZOCAINE Walgreens 253d7ea2-e48e-c7d7-e063-6394a90ae001 2025-08-12 Warnings Exact identifier application number: M022 Charm Tex FLUORIDE Gel SODIUM FLUORIDE Yangzhou Hongshengding Chemical Co.,Ltd. 897b0102-1c96-4699-908e-a7b7e26cd29f 2025-08-08 Warnings Exact identifier application number: M022 Meijer Enamel Guard POTASSIUM NITRATE, SODIUM FLUORIDE Meijer Distribution Inc 82bc95be-0a07-3f00-e053-2a91aa0a7438 2025-08-08 Warnings Exact identifier application number: M022 Topco Associates LLC Maximum Strength FLUORIDE Topco Associates LLC ac398ff0-0010-4e13-8b89-dc986fd7f974 2025-08-08 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE PLUS SOOTHING ALOE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 4ae4e88a-aaa5-4195-bedc-622fd5cd9394 2025-07-30 Warnings Exact identifier application number: M022 Aseptil Rojo PHENOL Menper Distributors, Inc. 62c96dc1-4698-43c1-8e6d-f4062dc5eea2 2025-07-22 Warnings Exact identifier application number: M022 Anestenka BENZOCAINE Menper Distributors, Inc 00a3f1bc-ddfe-47c6-8221-f48f91513503 2025-07-22 Warnings Exact identifier application number: M022 Cureforte Breath Reset MOUTH SPRAY STEEL CITY HEALTH PRIVATE LIMITED 38ddf1a7-29ab-cb8d-e063-6294a90ad34c 2025-07-21 Warnings Exact identifier application number: M022 SprinJene Natural Sensitivity and Gum POTASSIUM NITRATE Health and Natural Beauty USA Corp 3cb23e36-0e8c-4172-b4ae-859b58a2739f 2025-07-07 Warnings Exact identifier application number: M022 Normal Salt SODIUM CHLORIDE Twin Med LLC dc82ff0f-8600-373a-e053-2995a90a7505 2025-07-03 Warnings Exact identifier application number: M022 Sensodyne Pronamel Kids Berry Twist SODIUM FLUORIDE Haleon US Holdings LLC 69c07c36-b5e0-420b-ab29-7d1091386322 2025-07-03 Warnings Exact identifier application number: M022 DenTek Instant Pain Relief Maximum Strength BENZOCAINE DenTek Oral Care, Inc. ae92b76e-815a-4b4c-8128-bd045098caa5 2025-06-30 Warnings Exact identifier application number: M022 Sensodyne Clinical White Stain Protector POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 99037e59-53d6-492c-8fce-67641fc8efdd 2025-06-25 Warnings Exact identifier application number: M022 Iolite-S BENZOCAINE Dharma Research, Inc. b3b68914-2adc-4f07-9521-0b18756be522 2025-06-14 Warnings Exact identifier application number: M022 Red Cross Toothache EUGENOL The Mentholatum Company 3537e599-65d9-48d6-8a46-d42312f71e84 2025-06-11 Warnings Exact identifier application number: M022 QUALITY CHOICE Sore Throat PHENOL CHAIN DRUG MARKETING ASSOCIATION c95ee086-f384-475d-ad0c-75518cb9d2fe 2025-06-10 Warnings Exact identifier application number: M022 Onral Oral Pain Reliever Mouthwash BENZOCAINE Syka Pharma Inc. 5dd8d933-6f32-4eaf-8eca-9365d7de55a2 2025-06-03 Warnings Exact identifier application number: M022 Orajel Rescue Relief Pen ORAL PAIN RELIEVER Church & Dwight Co., Inc. 2d68eec5-ae8a-9cdf-e063-6294a90a9799 2025-06-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 9e1f7462-a052-4db4-bc59-cce437b695d0 2025-05-20 Warnings Exact identifier application number: M022 Saline 1.5 FL OZ SALINE ALAINA HEALTHCARE PRIVATE LIMITED f1bdbb25-6943-4828-9ae0-7d9783c18b5f 2025-05-19 Warnings Exact identifier application number: M022
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 69968-0400-1 69968040001 1500 mL in 1 BOTTLE, PLASTIC (69968-0400-1) 1500 ml 2019-01-06 0000-00-00 No No Current 69968-0400-2 69968040002 250 mL in 1 BOTTLE, PLASTIC (69968-0400-2) 250 ml 2019-01-06 0000-00-00 No No Current 69968-0400-3 69968040003 1000 mL in 1 BOTTLE, PLASTIC (69968-0400-3) 1000 ml 2019-01-06 0000-00-00 No No Current 69968-0400-5 69968040005 500 mL in 1 BOTTLE, PLASTIC (69968-0400-5) 500 ml 2019-01-06 0000-00-00 No No Current 69968-0400-8 69968040008 2 BOTTLE, PLASTIC in 1 PACKAGE (69968-0400-8) / 1500 mL in 1 BOTTLE, PLASTIC (69968-0400-1) 2019-01-06 0000-00-00 No No Current 69968-0400-9 69968040009 95 mL in 1 BOTTLE, PLASTIC (69968-0400-9) 95 ml 2019-01-06 0000-00-00 No No Current