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 26 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	69271b7a-18c0-4445-8164-cb1620fb5475	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	40bd7406-7ee6-47fe-8481-0a4c8cefce65	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	43194fe1-87a1-4ffa-ad73-a1dcec91fd63	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	b0b3ab27-704a-44b8-8473-d21ac3359ba1	2025-01-09	Warnings	Exact identifier application number: M022
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	39f64f10-f442-45a9-a060-9f99e78c678d	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	ed5a294a-fc03-43dd-825d-23a232060900	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	be558e5b-cf35-4035-a69c-8d66deeac6b2	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	a2591a96-ed66-45b1-abf6-6b26d0bb4f44	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	efe92e48-5086-4b61-a298-0d8ceefe100e	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	1d6a1182-ab63-460a-ab91-8d4c2ae5d01e	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	e1db79a4-4a24-4c3f-9ee9-2af3f876ac96	2025-01-09	Warnings	Exact identifier application number: M022
iSmile Topical Anesthetic	BENZOCAINE	iSmile Dental Products, Inc.	d3b6669e-479f-4bc1-b533-5e9a0cc65213	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	e42a22ef-1035-4dd0-94b0-43625542d584	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	3dca05de-cf63-4ca0-88be-473ea637e6b4	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2	2025-01-09	Warnings	Exact identifier application number: M022
Tiger Supply Inc Topical Anesthetic	BENZOCAINE	Tiger Supply Inc.	c6eda1de-4490-4a28-8a31-cbf3e102e74e	2025-01-09	Warnings	Exact identifier application number: M022
Comfortcaine Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	4261cd90-5087-44a3-bef9-72d33dbf0dfd	2025-01-09	Warnings	Exact identifier application number: M022
Comfortcaine Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	e70240a8-fa9d-4005-a3a0-5cca6188bf61	2025-01-09	Warnings	Exact identifier application number: M022
Comfortcaine Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	fda3d254-e103-4be9-9086-51ad022b2b3f	2025-01-09	Warnings	Exact identifier application number: M022
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	c161da79-9ea5-4c7f-890c-4315129fe5bf	2025-01-08	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	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