FDA.reportPublic FDA data

Act Total Care Anticavity Fluoride Fresh Mint

Product NDC
41167-0943
11-digit product format
411670943
Labeler code
41167
Product ID
41167-0943_ad53fe9a-e489-4db5-8708-2eee0db9b8fd
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
RINSE
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
Substance
SODIUM FLUORIDE
Active strength
.09 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Act Total Care Anticavity Fluoride Fresh Mint
Listing expiration
2026-12-31

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
dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0943-3Act Total Care Anticavity Fluoride Fresh Mint1000 mL in 1 BOTTLERINSE100011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3AACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0943ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]10Current NDC, Legacy NDC, 1 package rows20240802_dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8.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 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
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
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044540ACT 0.02 % (fluoride ion 0.009 % ) MouthwashPSNdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
1044540sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]SBDdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
313029sodium fluoride 0.2 MG/ML MouthwashSCDdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
1044540ACT Braces Care 0.02 % MouthwashSYdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
1044540ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) MouthwashSYdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
1044540ACT Fluoride Rinse 0.2 MG/ML MouthwashSYdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYdc209500-2bf4-42fb-b3a1-d0fb8d63dbd811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0943-3411670943031000 mL in 1 BOTTLE (41167-0943-3) 1000 ml2012-01-010000-00-00NoNoCurrent