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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	69968-0400	69968-0400-2	D	Discontinued by firm	2026-10-15
excluded package	package	69968-0400	69968-0400-5	D	Discontinued by firm	2026-10-15
excluded package	package	69968-0400	69968-0400-9	D	Discontinued by firm	2026-10-15

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.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	69968-0400-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69968-0400-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69968-0400-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	69968-0400-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69968-0400-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69968-0400-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	69968-0400-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69968-0400-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69968-0400-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	69968-0400-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69968-0400-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69968-0400-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	69968-0400-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69968-0400-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69968-0400-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	69968-0400-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69968-0400-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69968-0400-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	69968-0400-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69968-0400-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69968-0400-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	69968-0400-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69968-0400-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69968-0400-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	69968-0400-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69968-0400-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69968-0400-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	69968-0400-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69968-0400-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69968-0400-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	69968-0400-9	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	69968-0400-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	69968-0400-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	69968-0400-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	69968-0400-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	69968-0400-2	`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
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RV6J6604TK	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup
3J50XA376E	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
78e2e172-09a4-4bf1-9871-d099c49087be	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
69968-0400-1	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 9 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wintergreen Peppermint	POTASSIUM NITRATE, SODIUM FLUORIDE	Twice Twice LLC	7b7beec2-e070-4102-a2a4-68c332fc9fb3	2026-01-19	Warnings	Exact identifier application number: M022
GuruNanda Sensitive	POTASSIUM NITRATE	GURUNANDA, LLC	3ef0d3d4-fd42-0181-e063-6394a90af09c	2026-01-19	Warnings	Exact identifier application number: M022
Up and Up Antiseptic	CETYLPYRIDINIUM CHLORIDE	Target Corporation	386ee9f9-598e-ad00-e063-6394a90aeb46	2026-01-19	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	4a8f1d2f-b326-46d2-8914-d65ccc409edf	2026-01-18	Warnings	Exact identifier application number: M022
Colgate Sensitive Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	3b656928-af58-4ee9-8fb8-360688eb9bf3	2026-01-13	Warnings	Exact identifier application number: M022
Colgate Sensitive Enamel Health	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	a50d4259-8a79-417e-b381-72c7a8ec0418	2026-01-13	Warnings	Exact identifier application number: M022
Walgreens Sensitive Enamel Repair	SODIUM FLUORIDE	Walgreens	41d6384d-695b-b60b-e063-6394a90aa0b9	2026-01-09	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	HY-VEE, INC	47f738cc-7968-cc07-e063-6294a90af7ab	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Clinical White Stain Protector	SODIUM FLUORIDE	CVS Pharmacy	41d5c3a9-abe5-5528-e063-6294a90ada79	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Sensitive Enamel Repair	SODIUM FLUORIDE	CVS	41d547b3-2feb-8e83-e063-6294a90ae3cd	2026-01-09	Warnings	Exact identifier application number: M022
Moon Platinum Advanced Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care LLC	ded3a5a6-2883-f3de-e053-2a95a90afb94	2026-01-09	Warnings	Exact identifier application number: M022
Moon Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0bdcad3e-b8e9-bd91-e063-6394a90a666a	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive Prevent and Repair	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	e67410dc-a671-4611-8af1-097be071cd1c	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive plus Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	2092c747-e025-47a9-9e54-731631d3c831	2026-01-09	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2e7fbf9d-553c-c7bf-e063-6294a90a5f79	2026-01-08	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	47e2650f-4f50-8d85-e063-6394a90a1ddc	2026-01-08	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2b4b22e9-a03b-fb8f-e063-6394a90a8747	2026-01-08	Warnings	Exact identifier application number: M022
Crest 3D White Advanced	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f3aa9a59-b4d4-05d9-e053-2995a90a0aea	2026-01-08		Exact identifier application number: M022
Oral B Plaque Defense Special Care Oral Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d503fad5-a378-0e60-e053-2a95a90abe65	2026-01-08	Warnings	Exact identifier application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d5f69341-b659-c74a-e053-2a95a90a317e	2026-01-08	Warnings	Exact identifier application number: M022

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

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	78e2e172-09a4-4bf1-9871-d099c49087be	11
1043623	LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % Mouthwash	PSN	78e2e172-09a4-4bf1-9871-d099c49087be	11
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	78e2e172-09a4-4bf1-9871-d099c49087be	11
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	78e2e172-09a4-4bf1-9871-d099c49087be	11
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	78e2e172-09a4-4bf1-9871-d099c49087be	11
1043623	Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	78e2e172-09a4-4bf1-9871-d099c49087be	11

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