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 | 2026-10-05 |
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.
| 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 |
|---|---|---|---|---|---|---|
| GingiCaine Gel, Mint Julep | GINGICAINE GEL, MINT JULEP FLABVOR | Gingi-Pak a Division of the Belport | 6285fe10-08ba-8044-e053-2991aa0a8e8b | 2026-06-29 | Warnings | M022 |
| GingiCaine Gel, Pina Colada | GINGICAINE GEL, PINA COLADA FLAVOR | Gingi-Pak a Division of the Belport | 6284e1fe-be33-69bf-e053-2991aa0a90ab | 2026-06-29 | Warnings | M022 |
| GingiCaine Gel, Chocolate Mint | GINGICAINE GEL, CHOCOLATE MINT FLAVOR | Gingi-Pak a Division of the Belport | 6285c4f2-c139-49a9-e053-2991aa0a2b03 | 2026-06-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Bellport Company, Inc. dba Gingi-Pak | f5dd8fa8-0b6a-5a30-e053-2995a90ad194 | 2026-06-26 | Warnings | M022 |
| GingiCaine Gel | GINGICAINE GEL BANANA FLAVOR | Gingi-Pak a Division of the Belport | 62857d06-a829-4efa-e053-2991aa0a6d15 | 2026-06-25 | Warnings | M022 |
| GingiCaine Gel, Cotton Candy Flavor | GINGICAINE GEL, COTTON CANDY FLAVOR | Gingi-Pak a Division of the Belport | 628515a5-175f-ac2c-e053-2991aa0a19ce | 2026-06-25 | Warnings | M022 |
| Perox-A-Mint Solution | HYDROGEN PEROXIDE | Sage Products, LLC | 50823ff5-ad08-4449-bc4a-9a8ae25ec0d5 | 2026-06-24 | Warnings | M022 |
| Antiseptic Oral Rinse | CETYLPYRIDINIUM CHLORIDE | Sage Products LLC | efff8bae-154d-46bc-8dd4-716800425663 | 2026-06-24 | M022 | |
| Anbesol Maximum Strength | BENZOCAINE | Foundation Consumer Brands | 8c6ac499-9bd2-4ea5-9f26-df7947bff4a6 | 2026-06-22 | Warnings | M022 |
| Anbesol Maximum Strength | BENZOCAINE | Foundation Consumer Brands | dcc37403-0192-4658-bb7a-059273ce0047 | 2026-06-22 | Warnings | M022 |
| Toothache | POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE | Guchutang Biotechnology (Longyan) Co., Ltd | 54ad2ceb-272f-e5ba-e063-6394a90aec5f | 2026-06-20 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Delon Laboratories (1990) Ltd | d4aa09bf-8207-47dd-bc42-01e660da9438 | 2026-06-16 | Warnings | M022 |
| TideFresh MOUTH SORE AND TOOTHACHE | BENZOCAINE 20% MOUTH SORE AND TOOTHACHE | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 541e1814-c00e-efdf-e063-6394a90a41a1 | 2026-06-13 | Warnings | M022 |
| Chloraseptic Sore Throat Max | PHENOL AND GLYCERIN | Prestige Brands Holdings, Inc. | 882c940c-b3c3-4aa4-8d64-e4260f066ff4 | 2026-06-08 | Warnings | M022 |
| Orazen | SODIUM MONOFLUOROPHOSPHATE | Orazen Inc | fa5b6bd8-443f-79e7-e053-6394a90a5513 | 2026-06-03 | Warnings | M022 |
| Fishermans Friend Mixed Berry | MENTHOL | Lofthouse of Fleetwood | 53391c4d-ee2d-ade3-e063-6394a90ac77d | 2026-06-01 | Warnings | M022 |
| Orajel Medicated for Toothache and Gum, Liquid | BENZOCAINE AND MENTHOL | Church & Dwight Co., Inc. | ac3d605d-241d-1a6f-e053-2a95a90ae391 | 2026-06-01 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Reckitt Benckiser LLC | 6140d487-d87c-4954-9247-83492bcc5738 | 2026-05-27 | Warnings | M022 |
| Dolodent Maximum Strength | BENZOCAINE | Pharmadel LLC | 351ecc2b-cc1a-2bbf-e063-6394a90a5c14 | 2026-05-26 | Warnings | M022 |
| MOUTH ULCER | PANTHENOL | Guangzhou Shengli Shidai Cosmetics Co., Ltd. | 5264f81c-bffe-4f6d-e063-6394a90ae3bf | 2026-05-22 | 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 |