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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
3J50XA376E	Internal UNII lookup
RV6J6604TK	Internal UNII lookup
L7T10EIP3A	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
1043623	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
edb9e374-4dba-5823-e053-2a95a90a3da5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
69968-0791-1	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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier application number: M022
Chloraseptic Warming Sore Throat	PHENOL	Prestige Brands Holdings, Inc.	a197fab2-70ce-4a6c-9add-29d7368a75c5	2024-10-25	Warnings	Exact identifier application number: M022
Gly-Oxide	CARBAMIDE PEROXIDE	Medtech Products Inc.	086a0b82-e947-41c9-89e7-ba06483960c9	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	d500f423-b9f2-4d98-8f2a-8bab7c05737c	2024-10-25	Warnings	Exact identifier application number: M022
CHLORASEPTIC	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	b30e4b32-89dd-4e53-81d5-1415105361d4	2024-10-25	Warnings	Exact identifier application number: M022
Finafta MultiOral	BENZOCAINE	Efficient Laboratories Inc.	28c5a993-fb5f-4091-af15-32ccae4b9a7d	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Freshmint	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	7e715bb9-666e-4de4-ba70-1c84f5243443	2024-10-14	Warnings	Exact identifier application number: M022
Rexall Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	Old East Main CO.	2daf18a3-f71e-4585-8128-4663eff7eb6d	2024-10-14	Warnings	Exact identifier application number: M022
Anadent Kanka Gel	BENZOCAINE	BELMORA LLC	e0f73d78-5db1-43b4-8f58-e5410ca4560f	2024-10-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Navajo Manufacturing Company Inc.	f5f26e2f-8a1f-4687-e053-2a95a90ae378	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Navajo Manufacturing Company Inc.	f89bf259-b738-8229-e053-6394a90a0c59	2024-10-03	Warnings	Exact identifier application number: M022
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Navajo Manufacturing Company Inc.	f71c53e0-e2dd-16f9-e053-6394a90accff	2024-10-03	Warnings	Exact identifier application number: M022
Crest Pro Health	CETYLPYRIDINIUM CHLORIDE	Navajo Manufacturing Company Inc.	65bf17a9-21ad-27cb-e053-2991aa0afc40	2024-10-02	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	94e07979-943b-45bb-8e2b-90d686f3692e	2024-09-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Advanced Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	6eb304dd-2a24-4fa0-9d39-71264e88dd16	2024-08-29	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep Clean	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cfda7efa-86fa-470d-a79f-81907e31778a	2024-08-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Kids Bubble Twist	SODIUM FLUORIDE	Haleon US Holdings LLC	e403529a-0fac-4dab-b75c-46906add096b	2024-08-13	Warnings	Exact identifier application number: M022
Calcium Carbonate Assorted Flavors	ANTACID TABLETS	NuCare Pharmaceuticals,Inc.	af10dfb6-fef3-3410-e053-2995a90a9130	2024-07-17	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening Plus	POTASSIUM NITRATE	Haleon US Holdings LLC	f757ccdd-b316-4799-a34a-10edbb73da6b	2024-07-12	Warnings	Exact identifier application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE, SODIUM FLUORIDE	Lidl US, LLC	baef7f15-8082-4e61-8c08-8beda8ad40c0	2024-07-03	Warnings	Exact identifier application number: M022

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

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	edb9e374-4dba-5823-e053-2a95a90a3da5	7
1043623	LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % Mouthwash	PSN	edb9e374-4dba-5823-e053-2a95a90a3da5	7
1043623	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash [Listerine Antiseptic]	SBD	edb9e374-4dba-5823-e053-2a95a90a3da5	7
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	edb9e374-4dba-5823-e053-2a95a90a3da5	7
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	edb9e374-4dba-5823-e053-2a95a90a3da5	7
1043623	Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	edb9e374-4dba-5823-e053-2a95a90a3da5	7

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