FDA.reportPublic FDA data

ACT Total Care Anticavity Fluoride Icy Clean Mint

Product NDC
41167-0966
11-digit product format
411670966
Labeler code
41167
Product ID
41167-0966_75742efb-135b-4fb0-ae94-88cdee3d38c2
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
.09 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 packagepackage41167-096641167-0966-8DDiscontinued by firm2026-08-03

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…

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.09 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
1044540Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
258b78b4-55e7-410c-90f8-a3e456c02579Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0966-7ACT Total Care Anticavity Fluoride Icy Clean Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10009
41167-0966-8ACT Total Care Anticavity Fluoride Icy Clean Mint1250 mL in 1 BOTTLE, PLASTICMOUTHWASH12509

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.]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0966ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]8Current NDC, Legacy NDC, 2 package rows20231020_258b78b4-55e7-410c-90f8-a3e456c02579.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 1 of 52 · 1,024 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044540ACT 0.02 % (fluoride ion 0.009 % ) MouthwashPSN258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN258b78b4-55e7-410c-90f8-a3e456c025799
1044540sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]SBD258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.2 MG/ML MouthwashSCD258b78b4-55e7-410c-90f8-a3e456c025799
1044540ACT Braces Care 0.02 % MouthwashSY258b78b4-55e7-410c-90f8-a3e456c025799
1044540ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) MouthwashSY258b78b4-55e7-410c-90f8-a3e456c025799
1044540ACT Fluoride Rinse 0.2 MG/ML MouthwashSY258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY258b78b4-55e7-410c-90f8-a3e456c025799

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0966-7411670966071000 mL in 1 BOTTLE, PLASTIC (41167-0966-7) 1000 ml2009-02-010000-00-00NoNoCurrent
41167-0966-8411670966081250 mL in 1 BOTTLE, PLASTIC1250 mlHistorical