Listerine FreshBurst Antiseptic

Product NDC
42002-403
11-digit product format
420020403
Labeler code
42002
Product ID
42002-403_f7366cdc-4f1f-46cc-a93c-4493577ceb55
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, and Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Johnson & Johnson Consumer Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-02-21
Marketing end
2021-02-10
Substance
EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42002-403DDiscontinued by firm2026-10-05
excluded packagepackage42002-40342002-403-63DDiscontinued by firm2026-10-05
excluded packagepackage42002-40342002-403-70DDiscontinued by firm2026-10-05
excluded packagepackage42002-40342002-403-71DDiscontinued by firm2026-10-05
excluded packagepackage42002-40342002-403-72DDiscontinued by firm2026-10-05
excluded packagepackage42002-40342002-403-73DDiscontinued by firm2026-10-05
excluded packagepackage42002-40342002-403-94DDiscontinued by firm2026-10-05

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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-403-71d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-403-73d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-403-72d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-403-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-403-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42002-403-63d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-403-71f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-403-73f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-403-72f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-403-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-403-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42002-403-63f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-403-712ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-403-732ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-403-722ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-403-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-403-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42002-403-632ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-403-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-403-73a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-403-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-403-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-403-94a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42002-403-63a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-403-71cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-403-73cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-403-72cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-403-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-403-94cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42002-403-63cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-403-71cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-403-73cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-403-72cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-403-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-403-94cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42002-403-63cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-403-71302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-403-73302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-403-72302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-403-70302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-403-94302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42002-403-63302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-403-71ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-403-73ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-403-72ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-403-70ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-403-94ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42002-403-63ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42002-403-710efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42002-403-730efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42002-403-720efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EucalyptolACTIVE INGREDIENTRV6J6604TKLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Menthol, unspecified formACTIVE INGREDIENTL7T10EIP3ALISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Methyl SalicylateACTIVE INGREDIENTLAV5U5022YLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
ThymolACTIVE INGREDIENT3J50XA376ELISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
EucalyptolACTIVE MOIETYRV6J6604TKLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Menthol, unspecified formACTIVE MOIETYL7T10EIP3ALISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Salicylic AcidACTIVE MOIETYO414PZ4LPZLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
ThymolACTIVE MOIETY3J50XA376ELISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
AlcoholINACTIVE INGREDIENT3K9958V90MLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
FD&C Green No. 3INACTIVE INGREDIENT3P3ONR6O1SLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2LISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EULISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
SorbitolINACTIVE INGREDIENT506T60A25RLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RLISTERINE FRESHBURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, AND THYMOL) MOUTHWASH [JOHNSON & JOHNSON CONSUMER INC.]3