FDA.reportPublic FDA data

ACT Anticavity Fluoride Cinnamon

Product NDC
41167-0940
11-digit product format
411670940
Labeler code
41167
Product ID
41167-0940_036301d0-8cd9-4c15-871f-0a8e1651292b
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
1994-04-01
Substance
SODIUM FLUORIDE
Active strength
.2 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACT Anticavity Fluoride Cinnamon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui240698, 656809

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
41167-0940-8ACT Anticavity Fluoride Cinnamon532 mL in 1 BOTTLE, DISPENSINGRINSE53211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SORBITOLINACTIVE INGREDIENT506T60A25RACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0940ACT ANTICAVITY FLUORIDE CINNAMON (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]10Current NDC, Legacy NDC, 1 package rows20241004_f2952ca5-c1c3-42fc-82a4-08662286be44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSNf2952ca5-c1c3-42fc-82a4-08662286be4411
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNf2952ca5-c1c3-42fc-82a4-08662286be4411
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBDf2952ca5-c1c3-42fc-82a4-08662286be4411
240698sodium fluoride 0.5 MG/ML MouthwashSCDf2952ca5-c1c3-42fc-82a4-08662286be4411
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSYf2952ca5-c1c3-42fc-82a4-08662286be4411
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSYf2952ca5-c1c3-42fc-82a4-08662286be4411
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYf2952ca5-c1c3-42fc-82a4-08662286be4411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0940-841167094008532 mL in 1 BOTTLE, DISPENSING (41167-0940-8) 532 ml1994-04-010000-00-00NoNoCurrent