ACT Total Care Anticavity Fluoride Icy Clean Mint

Product NDC
41167-0965
11-digit product format
411670965
Labeler code
41167
Product ID
41167-0965_a744913f-a455-4516-b739-8ac879671512
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
MOUTHWASH
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-02-01
Substance
SODIUM FLUORIDE
Active strength
.2 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41167-096541167-0965-3DDiscontinued 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
ACT Total Care Anticavity Fluoride Icy Clean Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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
240698Internal RxNorm lookup
656809Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
beded786-bb55-4ba3-82fe-9e9d1b5e2979Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0965-0ACT Total Care Anticavity Fluoride Icy Clean Mint532 mL in 1 BOTTLE, PLASTICMOUTHWASH5329
41167-0965-3ACT Total Care Anticavity Fluoride Icy Clean Mint88 mL in 1 BOTTLE, PLASTICMOUTHWASH889

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0965ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]8Current NDC, Legacy NDC, 2 package rows20231230_beded786-bb55-4ba3-82fe-9e9d1b5e2979.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 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SprinJene White BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp8c401bea-0148-46a0-bbb3-80c17f9e8e3e2026-08-14WarningsExact identifier
application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-13WarningsExact identifier
application number: M021
COLGATE STRAWBERRY BURSTSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-13WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRYSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.e36ceb7a-9a29-41d8-8d08-a859e515f1f52026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.08d7ed04-67a4-437a-82c5-496f9893c6c72026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.27278b02-c4fd-4092-a632-a14e442f5a952026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICESODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.59a6b9ac-c28b-4ec3-8231-f35054ce0eaf2026-08-10WarningsExact identifier
application number: M021
Toms Kids Watermelon WiggleSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.48eaafb6-99f4-5fd1-10fc-4ea35cbb2c622026-08-10WarningsExact identifier
application number: M021
AutoBrush kids bubblegumSODIUM FLUORIDELander Enterprises, LLC64b60e74-fceb-4de9-a966-73bf8dbd666c2026-08-10WarningsExact identifier
application number: M021
AutoBrush kids strawberrySODIUM FLUORIDELander Enterprises, LLC7e880d50-8aab-4d57-abc1-e900070f9a112026-08-10WarningsExact identifier
application number: M021
AutoBrush kids watermelonSODIUM FLUORIDELander Enterprises, LLC5cb5eb46-705c-4bb7-bef1-e93a598636fd2026-08-10WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC0e043431-9d87-478d-87f5-5aa8b0a932eb2026-08-10WarningsExact identifier
application number: M021
Willo Minty Mist Dye FreeSODIUM FLUORIDEWillo 32, Inc.3ee5b49e-ca9a-ece6-e063-6394a90a3d002026-08-10WarningsExact identifier
application number: M021
Willo Bubble TwistSODIUM FLUORIDEWillo 32 Inc36560d62-e901-1f93-e063-6394a90a28032026-08-10WarningsExact identifier
application number: M021
Willo Berry Splash Dye FreeSODIUM FLUORIDEWillo 32, Inc3ea91af9-2895-e530-e063-6394a90a39e52026-08-10WarningsExact identifier
application number: M021
Fluoride Mouth Rinse AnticavitySODIUM FLUORIDETarget Corporation3daf3cc3-585a-4bb2-9b56-7117d220ed382026-08-10Warnings, Adverse reactionsExact identifier
application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGOSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.19de1e71-ab94-415f-b66d-e5748dea83172026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.d5e1396e-0253-4ec0-a9ff-b61bda70de352026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED COOL MILD MINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.de92408c-d401-47c3-94ee-fb6c080926512026-08-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSNbeded786-bb55-4ba3-82fe-9e9d1b5e29799
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNbeded786-bb55-4ba3-82fe-9e9d1b5e29799
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBDbeded786-bb55-4ba3-82fe-9e9d1b5e29799
240698sodium fluoride 0.5 MG/ML MouthwashSCDbeded786-bb55-4ba3-82fe-9e9d1b5e29799
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSYbeded786-bb55-4ba3-82fe-9e9d1b5e29799
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSYbeded786-bb55-4ba3-82fe-9e9d1b5e29799
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYbeded786-bb55-4ba3-82fe-9e9d1b5e29799

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0965-041167096500532 mL in 1 BOTTLE, PLASTIC (41167-0965-0) 532 ml2009-02-010000-00-00NoNoCurrent
41167-0965-34116709650388 mL in 1 BOTTLE, PLASTIC88 mlHistorical