FDA.reportPublic FDA data

ACT Total Care Anticavity Fluoride Icy Clean Mint

Product NDC
41167-0966
11-digit product format
411670966
Labeler code
41167
Product ID
41167-0966_75742efb-135b-4fb0-ae94-88cdee3d38c2
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
2009-02-01
Substance
SODIUM FLUORIDE
Active strength
.09 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 Total Care Anticavity Fluoride Icy Clean Mint
Listing expiration
2027-12-31

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0966-7ACT Total Care Anticavity Fluoride Icy Clean Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10009
41167-0966-8ACT Total Care Anticavity Fluoride Icy Clean Mint1250 mL in 1 BOTTLE, PLASTICMOUTHWASH12509

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0966ACT TOTAL CARE ANTICAVITY FLUORIDE ICY CLEAN MINT (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]8Current NDC, Legacy NDC, 2 package rows20231020_258b78b4-55e7-410c-90f8-a3e456c02579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044540ACT 0.02 % (fluoride ion 0.009 % ) MouthwashPSN258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN258b78b4-55e7-410c-90f8-a3e456c025799
1044540sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]SBD258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.2 MG/ML MouthwashSCD258b78b4-55e7-410c-90f8-a3e456c025799
1044540ACT Braces Care 0.02 % MouthwashSY258b78b4-55e7-410c-90f8-a3e456c025799
1044540ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) MouthwashSY258b78b4-55e7-410c-90f8-a3e456c025799
1044540ACT Fluoride Rinse 0.2 MG/ML MouthwashSY258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY258b78b4-55e7-410c-90f8-a3e456c025799
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY258b78b4-55e7-410c-90f8-a3e456c025799

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0966-7411670966071000 mL in 1 BOTTLE, PLASTIC (41167-0966-7) 1000 ml2009-02-010000-00-00NoNoCurrent
41167-0966-8411670966081250 mL in 1 BOTTLE, PLASTIC1250 mlHistorical