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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui313029, 1044540

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

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