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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3J50XA376E	Internal UNII lookup
RV6J6604TK	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee467ec4-bd5e-644a-e053-2a95a90ac273	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry	FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	3573f149-2af9-4c86-e063-6294a90a7b3f	2025-05-18	Warnings	Exact identifier application number: M022
Bubble Gum Flavor For Kids 25g 50g	BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	354c1eda-ec5b-a8c7-e063-6294a90a871d	2025-05-16	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safeway, Inc.	8fe2f1df-3264-455d-b62c-953dce171c02	2025-05-16	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath Freshener	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	32b632bf-058d-447b-a7fb-a9dd05c1e2b8	2025-05-08	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Clear Mint	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	444f931d-5e38-4cda-97ba-98aa0b5fe4f6	2025-05-08	Warnings	Exact identifier application number: M022
Listerine Clinical Solutions Gum Health Icy Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	06e1122b-1100-43c0-e063-6394a90a2e78	2025-04-22	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	5260258a-bb1e-43d6-bce1-70a38778a64a	2025-04-14	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	TARGET Corporation	93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65	2025-04-14	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee467ec4-bd5e-644a-e053-2a95a90ac273	2025-04-10	Warnings	Exact identifier application number: M022 ndc (product): 69968-0788
Mouthwash	MENTHOL, METHYL SALICYLATE, THYMOL	Orazen Inc	873c43df-1d46-359b-e053-2a91aa0a4319	2025-04-07	Warnings	Exact identifier application number: M022
Sensodyne Complete Protection Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	e3cc3146-8aed-4f6b-a252-e379418c2b8d	2025-03-26	Warnings	Exact identifier application number: M022
Listerine Freshburst Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee1e1df9-74c6-d24b-e053-2a95a90a43d3	2025-03-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	edb9e374-4dba-5823-e053-2a95a90a3da5	2025-03-03	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Good Sense (Geiss, Destin & Dunn, Inc.)	cfe9be26-e4a4-413c-a602-2f5948e3bb7a	2025-03-03	Warnings	Exact identifier application number: M022
LISTERINE Original Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	78e2e172-09a4-4bf1-9871-d099c49087be	2025-02-28	Warnings	Exact identifier application number: M022
WHITE GLO CHARCOAL SENSITIVE	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	a5edb7fd-c637-5447-e053-2995a90a5a6f	2025-02-26	Warnings	Exact identifier application number: M022
Glorysmile Toothpaste.	GLORYSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	2ef48156-904d-e42a-e063-6394a90a3cd0	2025-02-25	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Walgreens	c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa	2025-02-21	Warnings	Exact identifier application number: M022
Sheffield Pain Relief	BENZOCAINE	Sheffield Pharmaceuticals LLC	e21abfdd-373d-42af-9535-fe1571382a65	2025-02-19	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Whole Foods Market	a2bb142e-8cbe-481e-bf4f-810ca6d14591	2025-02-12	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3J50XA376E	THYMOL	89-83-8	THYMOL
RV6J6604TK	EUCALYPTOL	470-82-6	EUCALYPTOL
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	PSN	ee467ec4-bd5e-644a-e053-2a95a90ac273	6
2043303	LISTERINE ULTRACLEAN 0.092 % / 0.042 % / 0.06 % / 0.064 % Mouthwash	PSN	ee467ec4-bd5e-644a-e053-2a95a90ac273	6
2043303	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Ultraclean]	SBD	ee467ec4-bd5e-644a-e053-2a95a90ac273	6
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	ee467ec4-bd5e-644a-e053-2a95a90ac273	6
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	ee467ec4-bd5e-644a-e053-2a95a90ac273	6
2043303	Listerine Ultraclean (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	ee467ec4-bd5e-644a-e053-2a95a90ac273	6
2043303	Listerine Ultraclean Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	ee467ec4-bd5e-644a-e053-2a95a90ac273	6

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