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	2026-09-14
excluded package	package	69968-0400	69968-0400-5	D	Discontinued by firm	2026-09-14
excluded package	package	69968-0400	69968-0400-9	D	Discontinued by firm	2026-09-14

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…`

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 1 of 42 · 825 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Opalescence Whitening Sensitivity Relief	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	44e94663-895b-67da-e063-6394a90a5fe6	2026-09-09	Warnings	Exact identifier application number: M022
Opalescence Sensitivity Relief Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	b5176a84-76a3-4ad0-a2e2-4997a12da9a5	2026-09-09	Warnings	Exact identifier application number: M022
Opal by Opalescence Sensitivity	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	5ffc0d14-0290-47bb-90e5-90a25a5acc28	2026-09-09	Warnings	Exact identifier application number: M022
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier application number: M022
SORE THROAT	PHENOL	Raritan Pharmaceuticals Inc	43ce374a-824c-4034-bf04-c351b4d8015b	2026-09-08	Warnings	Exact identifier application number: M022
Colgate Optic White Stain Fighter Sens Relief	SODIUM FLUORIDE	Colgate-Palmolive Company	6ec2fff7-df44-4302-be2d-97946c6cd66a	2026-09-08	Warnings	Exact identifier application number: M022
DRx Choice Sore Throat Menthol Flavor	PHENOL	RARITAN PHARMACEUTICALS INC	e3269b12-5c05-45a6-81f2-65d9f016c3aa	2026-09-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	0733015b-e81a-4a62-82ad-dacaf3f163cb	2026-09-02	Warnings	Exact identifier application number: M022
KROGER Saline	NASAL	KROGER COMPANY	c84b242b-f46e-4ea8-a3c1-109a47644646	2026-09-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	ceb125d9-8c1b-498c-b0f0-f18756ede442	2026-09-01	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT	HEXYLRESORCINOL	Reckitt Benckiser LLC	91cd2964-5d83-4e40-bc18-e3e5462f454a	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier application number: M022
LUDENS SUGAR FREE WILD CHERRY THROAT	PECTIN	Prestige Brands Holdings, Inc.	274fc80c-e5b2-41c7-a119-287d6e8a2258	2026-08-28	Warnings	Exact identifier application number: M022
Medline Peroxi Fresh Mouthwash	HYDROGEN PEROXIDE	Medline Industries, LP	ec7a9240-6c66-4471-b8b6-776e08a14fbc	2026-08-27	Warnings	Exact identifier application number: M022
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M022
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	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