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	2026-10-16
excluded package	package	69968-0400	69968-0400-5	D	Discontinued by firm	2026-10-16
excluded package	package	69968-0400	69968-0400-9	D	Discontinued by firm	2026-10-16

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 15 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Target Sensitive Whitening TP	SODIUM FLUORIDE	Target	ab9a129e-337b-31fe-e053-2995a90ac691	2025-11-14	Warnings	Exact identifier application number: M022
Signature Care Sensitive Maximum Strength	POTASSIUM NITRATE, SODIUM FLUORIDE	Safeway	83225fe5-0490-eb4b-e053-2a91aa0a6879	2025-11-14	Warnings	Exact identifier application number: M022
Rite Aid Extra Whitening	FLUORIDE	Rite Aid	efe2c6c1-b8c6-4a52-b3c6-c9bfca450570	2025-11-14	Warnings	Exact identifier application number: M022
Sound Body Sensitive Maximum Strength	POTASSIUM NITRATE, SODIUM FLUORIDE	Big Lots Stores, Inc.	81a0a712-76e1-133f-e053-2a91aa0a001a	2025-11-14	Warnings	Exact identifier application number: M022
Top Care Enamel Guard	FLUORIDE	TOPCO Assoc. LLC	8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c	2025-11-14	Warnings	Exact identifier application number: M022
Care One Maximum Strength	FLUORIDE	American Sales	24715cc7-cf02-4ea0-a491-2a111ad3660e	2025-11-14	Warnings	Exact identifier application number: M022
Kroger Enamel Protection Sensitive Gentle Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	Kroger Company	82b9a954-2a53-ac56-e053-2991aa0abd0e	2025-11-13	Warnings	Exact identifier application number: M022
Sensitive Extra Whitening	SODIUM FLUORIDE	Publix Super Market	16eddce3-03e4-4c0e-e063-6294a90ae94d	2025-11-13	Warnings	Exact identifier application number: M022
Pronamel Repair Whitening	PRONAMEL REPAIR WHITENING	Publix Super Market Inc	16ee2625-3641-205d-e063-6394a90a742f	2025-11-13	Warnings	Exact identifier application number: M022
Rite Aid Maximum Strength	BENZOCAINE	Rite Aid	340ccdab-0a02-454c-8d44-ced5667276ab	2025-11-13	Warnings	Exact identifier application number: M022
3x Medicated Mouth Sore Gel	BENZOCAINE	CVS	a7572c4f-089b-0e80-e053-2a95a90a0ddf	2025-11-13	Warnings	Exact identifier application number: M022
3x Medicated Mouth Sore Gel	BENZOCAINE	Walgreens	ad509f2a-05de-6c77-e053-2995a90ae526	2025-11-13	Warnings	Exact identifier application number: M022
TopCare Oral Pain Relief Maximum Strength	BENZOCAINE	Topco Associates LLC	835fb6ac-dbb7-5566-e053-2991aa0af5e2	2025-11-13	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Gel	BENZOCAINE	Walgreens	a71c47de-d35d-49da-e053-2995a90a823c	2025-11-13	Warnings	Exact identifier application number: M022
4X Medicated Toothache and Gum Gel	BENZOCAINE	Walmart	a471a858-edbf-c31e-e053-2995a90a7156	2025-11-13	Warnings	Exact identifier application number: M022
4X Medicated Severe Toothache and Gum Cream	BENZOCAINE	Rite Aid	996fdbeb-1fe3-77b6-e053-2995a90a25c7	2025-11-13	Warnings	Exact identifier application number: M022
Topco 4x Medicated Toothache and Gum Gel	BENZOCAINE	TopCare	b463ea94-08a9-ca5d-e053-2a95a90a224b	2025-11-13	Warnings	Exact identifier application number: M022
4X Medicated Severe Toothache and Gum Gel	BENZOCAINE	Rite Aid	99703bf4-f169-5e05-e053-2995a90afab4	2025-11-13	Warnings	Exact identifier application number: M022
3X Medicated Mouth Sore Gel	BENZOCAINE	Rite Aid	997064c9-24bb-7fb1-e053-2995a90ace7c	2025-11-13	Warnings	Exact identifier application number: M022
Quality Choice Natural White	FLUORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	8d187823-7e56-441b-8bca-8f03e7bb07c7	2025-11-12	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