FDA.reportPublic FDA data

ACT Restoring Anticavity Fluoride Cool Mint

Product NDC
41167-0981
11-digit product format
411670981
Labeler code
41167
Product ID
41167-0981_125e5c98-dc8c-4b48-9b1c-7e6557d2ea96
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
2006-02-01
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 Restoring Anticavity Fluoride Cool Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.09 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui313029, 1044540

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
41167-0981-2ACT Restoring Anticavity Fluoride Cool Mint1250 mL in 1 BOTTLE, PLASTICMOUTHWASH125014
41167-0981-7ACT Restoring Anticavity Fluoride Cool Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100014

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0981ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]13Current NDC, Legacy NDC, 2 package rows20241004_3409a749-4a1a-4950-8c21-364d1b977af7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044540ACT 0.02 % (fluoride ion 0.009 % ) MouthwashPSN3409a749-4a1a-4950-8c21-364d1b977af714
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN3409a749-4a1a-4950-8c21-364d1b977af714
1044540sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]SBD3409a749-4a1a-4950-8c21-364d1b977af714
313029sodium fluoride 0.2 MG/ML MouthwashSCD3409a749-4a1a-4950-8c21-364d1b977af714
1044540ACT Braces Care 0.02 % MouthwashSY3409a749-4a1a-4950-8c21-364d1b977af714
1044540ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) MouthwashSY3409a749-4a1a-4950-8c21-364d1b977af714
1044540ACT Fluoride Rinse 0.2 MG/ML MouthwashSY3409a749-4a1a-4950-8c21-364d1b977af714
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY3409a749-4a1a-4950-8c21-364d1b977af714
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY3409a749-4a1a-4950-8c21-364d1b977af714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0981-2411670981021250 mL in 1 BOTTLE, PLASTIC1250 mlHistorical
41167-0981-7411670981071000 mL in 1 BOTTLE, PLASTIC (41167-0981-7) 1000 ml2006-02-010000-00-00NoNoCurrent