FDA.reportPublic FDA data

Listerine Total Care Fresh Mint

Product NDC
69968-0178
11-digit product format
699680178
Labeler code
69968
Product ID
69968-0178_5a1d0276-f512-32ce-e063-6394a90a038b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-11-01
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69968-017869968-0178-1DDiscontinued by firm2026-10-16
excluded packagepackage69968-017869968-0178-2DDiscontinued by firm2026-10-16
excluded packagepackage69968-017869968-0178-3DDiscontinued by firm2026-10-16
excluded packagepackage69968-017869968-0178-4DDiscontinued by firm2026-10-16

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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 Total Care Fresh Mint
Brand name suffix
Anticavity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup
1798474Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2ce66c3-dc48-47a5-a731-5550bc194679Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0178-1Listerine Total Care Fresh MintAnticavity250 mL in 1 BOTTLE, PLASTICMOUTHWASH2507
69968-0178-2Listerine Total Care Fresh MintAnticavity500 mL in 1 BOTTLE, PLASTICMOUTHWASH5007
69968-0178-3Listerine Total Care Fresh MintAnticavity95 mL in 1 BOTTLE, PLASTICMOUTHWASH957
69968-0178-4Listerine Total Care Fresh MintAnticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10007
69968-0178-5Listerine Total Care Fresh MintAnticavity2 in 1 PACKAGEMOUTHWASH27
69968-0178-5Listerine Total Care Fresh MintAnticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10007
69968-0178-6Listerine Total Care Fresh MintAnticavity3 in 1 PACKAGEMOUTHWASH37
69968-0178-6Listerine Total Care Fresh MintAnticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0178LISTERINE TOTAL CARE FRESH MINT ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 8 package rows20241114_b2ce66c3-dc48-47a5-a731-5550bc194679.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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNb2ce66c3-dc48-47a5-a731-5550bc1946797
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNb2ce66c3-dc48-47a5-a731-5550bc1946797
1798474sodium fluoride 0.2 MG/ML Mouthwash [Listerine]SBDb2ce66c3-dc48-47a5-a731-5550bc1946797
313029sodium fluoride 0.2 MG/ML MouthwashSCDb2ce66c3-dc48-47a5-a731-5550bc1946797
1798474Listerine 0.02 % (fluoride ion 0.01 % ) Oral RinseSYb2ce66c3-dc48-47a5-a731-5550bc1946797
1798474Listerine 0.2 MG/ML MouthwashSYb2ce66c3-dc48-47a5-a731-5550bc1946797
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYb2ce66c3-dc48-47a5-a731-5550bc1946797
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYb2ce66c3-dc48-47a5-a731-5550bc1946797

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0178-169968017801250 mL in 1 BOTTLE, PLASTIC (69968-0178-1) 250 ml2009-11-010000-00-00NoNoCurrent
69968-0178-269968017802500 mL in 1 BOTTLE, PLASTIC (69968-0178-2) 500 ml2009-11-010000-00-00NoNoCurrent
69968-0178-36996801780395 mL in 1 BOTTLE, PLASTIC (69968-0178-3) 95 ml2009-11-010000-00-00NoNoCurrent
69968-0178-4699680178041000 mL in 1 BOTTLE, PLASTIC (69968-0178-4) 1000 ml2009-11-010000-00-00NoNoCurrent
69968-0178-5699680178052 BOTTLE, PLASTIC in 1 PACKAGE (69968-0178-5) / 1000 mL in 1 BOTTLE, PLASTIC2009-11-01NoNoCurrent
69968-0178-6699680178063 BOTTLE, PLASTIC in 1 PACKAGE (69968-0178-6) / 1000 mL in 1 BOTTLE, PLASTIC2009-11-01NoNoCurrent