FDA.reportPublic FDA data

ACT Anticavity Fluoride Mint

Product NDC
41167-0942
11-digit product format
411670942
Labeler code
41167
Product ID
41167-0942_553dd6cd-4557-4444-8a0c-a36efa8a008e
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 Mint
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
41167-0942-1ACT Anticavity Fluoride Mint30 mL in 1 BOTTLE, PLASTICRINSE3015
41167-0942-3ACT Anticavity Fluoride Mint88 mL in 1 BOTTLE, PLASTICRINSE8815
41167-0942-8ACT Anticavity Fluoride Mint532 mL in 1 BOTTLE, DISPENSINGRINSE53215

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
SORBITOLINACTIVE INGREDIENT506T60A25RACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0942ACT ANTICAVITY FLUORIDE MINT (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]14Current NDC, Legacy NDC, 3 package rows20241015_e81c83a2-363a-442f-8731-2598a4f4c21e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSNe81c83a2-363a-442f-8731-2598a4f4c21e15
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNe81c83a2-363a-442f-8731-2598a4f4c21e15
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBDe81c83a2-363a-442f-8731-2598a4f4c21e15
240698sodium fluoride 0.5 MG/ML MouthwashSCDe81c83a2-363a-442f-8731-2598a4f4c21e15
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSYe81c83a2-363a-442f-8731-2598a4f4c21e15
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSYe81c83a2-363a-442f-8731-2598a4f4c21e15
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYe81c83a2-363a-442f-8731-2598a4f4c21e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0942-14116709420130 mL in 1 BOTTLE, PLASTIC (41167-0942-1) 30 ml1994-04-010000-00-00NoNoCurrent
41167-0942-34116709420388 mL in 1 BOTTLE, PLASTIC88 mlHistorical
41167-0942-841167094208532 mL in 1 BOTTLE, DISPENSING (41167-0942-8) 532 ml1994-04-010000-00-00NoNoCurrent