FDA.reportPublic FDA data

ACT Restoring Anticavity Fluoride Cool Mint

Product NDC
41167-0957
11-digit product format
411670957
Labeler code
41167
Product ID
41167-0957_e957eb42-3732-49b1-93e2-456b5f9a9447
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
.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 Restoring Anticavity Fluoride Cool 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
41167-0957-5ACT Restoring Anticavity Fluoride Cool Mint532 mL in 1 BOTTLE, PLASTICMOUTHWASH53211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
SORBITOLINACTIVE INGREDIENT506T60A25RACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0957ACT RESTORING ANTICAVITY FLUORIDE COOL MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]10Current NDC, Legacy NDC, 1 package rows20240802_ef63e193-5804-4b35-bae7-cad29cf4e8bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656809ACT 0.05 % (fluoride ion 0.02 % ) MouthwashPSNef63e193-5804-4b35-bae7-cad29cf4e8bc11
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNef63e193-5804-4b35-bae7-cad29cf4e8bc11
656809sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]SBDef63e193-5804-4b35-bae7-cad29cf4e8bc11
240698sodium fluoride 0.5 MG/ML MouthwashSCDef63e193-5804-4b35-bae7-cad29cf4e8bc11
656809ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) MouthwashSYef63e193-5804-4b35-bae7-cad29cf4e8bc11
656809ACT Fluoride Rinse 0.5 MG/ML MouthwashSYef63e193-5804-4b35-bae7-cad29cf4e8bc11
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYef63e193-5804-4b35-bae7-cad29cf4e8bc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0957-541167095705532 mL in 1 BOTTLE, PLASTIC (41167-0957-5) 532 ml2006-02-010000-00-00NoNoCurrent