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.
| 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.
| 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 |
|---|---|
| EUCALYPTOL | .92 mg/mL |
| MENTHOL, UNSPECIFIED FORM | .42 mg/mL |
| METHYL SALICYLATE | .6 mg/mL |
| THYMOL | .64 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RV6J6604TK | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| LAV5U5022Y | Internal UNII lookup |
| 3J50XA376E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | af430cf4-f1b4-4b57-b8e3-87df96d655d3 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 2b089fec-cae3-4dc9-964d-d37f732a2f9f | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 6c137a93-4a34-4849-997f-bd0c572466ef | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | e8aa9709-e8f6-47a6-ab29-1fef2309786b | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 8c55b39c-8231-46a1-92ef-9fb4e3f40c1e | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9e82dc54-aeca-457f-b4b9-2f18cc269538 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 1a8f5964-770a-4d14-a7b6-18b5da9159b0 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | b0e5dc67-da7a-42ac-8657-e8e4da6914be | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721ff57-0111-4bbb-e053-2995a90a1a70 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 8129e871-5f31-4138-ae47-f8978fa6287f | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 0301c1bc-db48-4635-97f5-9eaef7ab9579 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | c0c88180-ccdc-4c48-b262-3ec20d4775d4 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | ba011795-6822-4fff-b9c8-5c91cf9972a7 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 462a5f09-131f-4dfa-a502-547c44e4a4a5 | 2025-01-16 | Warnings | M022 |
| Benzocaine | TOPICAL ANESTHETIC | Everpharm LLC | 2bc57111-0f15-b237-e063-6294a90a4471 | 2025-01-15 | Warnings | M022 |
| Kanka Triple Action | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | 078fcdab-38a1-4a9a-bdd3-e17446591ea8 | 2025-01-09 | Warnings | M022 |
DailyMed RxNorm Mappings#
| 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 | 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 |