Listerine FreshBurst Antiseptic

Product NDC: 69968-0239
11-digit product format: 699680239
Labeler code: 69968
Product ID: 69968-0239_22634de5-9318-1b56-e063-6394a90a6245
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: 2018-08-17
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69968-0239	69968-0239-8	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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 FreshBurst 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
62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	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
69968-0239-1	Listerine FreshBurst Antiseptic	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000	9
69968-0239-2	Listerine FreshBurst Antiseptic	250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	250	9
69968-0239-3	Listerine FreshBurst Antiseptic	1500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1500	9
69968-0239-5	Listerine FreshBurst Antiseptic	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500	9
69968-0239-8	Listerine FreshBurst Antiseptic	2 in 1 PACKAGE	MOUTHWASH	2	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0239	LISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [KENVUE BRANDS LLC]	9	Current NDC, Legacy NDC, 5 package rows	20241114_62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8.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 25 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	0192ccf9-1715-4e23-a6bf-8bd838cd8b0d	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	edcb8451-6fa7-4bc2-95f6-2a0806f7f3da	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	576660ed-203a-4842-9d39-c5be10daf976	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	1796b3ec-833a-4cf1-ba50-bc4da827f84f	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	d923fa75-f556-45e3-9f52-39a62e89984b	2025-01-09	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	cd3ede8c-2c77-4d81-8dff-8198025a2156	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f5f9b-4192-15e6-e053-2995a90a6457	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	2b494372-de59-e462-e063-6294a90a08da	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	a225d515-430d-4e34-846c-0bfec3e74109	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	372f99c9-4ad3-4631-b8c8-2a34c47343cc	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	e554b5b2-cf91-464a-a930-3e1087f12c8d	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	98da331c-76c2-49fe-b687-6bfba4ae2e75	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d2195efa-597d-4ba9-a9b0-8df0d8f49311	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	fba82d55-94db-4432-b532-603fe57202be	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	9ed0fe31-e5f2-4d6d-8686-1286c6659847	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d5f42c30-343c-4e1d-950c-89bbd361fd27	2025-01-09	Warnings	Exact identifier application number: M022
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	7dce407f-bbe4-4a27-97ff-be33fd447461	2025-01-09	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	cb7f28f3-a908-47a9-e053-2995a90a6cbd	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	a80cfd29-8314-4639-a811-afd5fdb630b0	2025-01-09	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	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	9
1043623	LISTERINE Antiseptic 0.092 % / 0.042 % / 0.06 % / 0.064 % Mouthwash	PSN	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	9
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	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	9
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	9
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	9
1043623	Listerine Antiseptic (eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % ) Mouthwash	SY	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0239-1	69968023901	1000 mL in 1 BOTTLE, PLASTIC (69968-0239-1)	1000 ml	2018-09-18	0000-00-00	No	No	Current
69968-0239-2	69968023902	250 mL in 1 BOTTLE, PLASTIC (69968-0239-2)	250 ml	2019-05-03	0000-00-00	No	No	Current
69968-0239-3	69968023903	1500 mL in 1 BOTTLE, PLASTIC (69968-0239-3)	1500 ml	2018-08-28	0000-00-00	No	No	Current
69968-0239-5	69968023905	500 mL in 1 BOTTLE, PLASTIC (69968-0239-5)	500 ml	2018-08-17	0000-00-00	No	No	Current
69968-0239-8	69968023908	2 BOTTLE, PLASTIC in 1 PACKAGE (69968-0239-8) > 1500 mL in 1 BOTTLE, PLASTIC (69968-0239-3)		2020-04-24	0000-00-00	No	No	Current