FDA.reportPublic FDA data

ACT Total Care Dry Mouth Anticavity Mouth

Product NDC
41167-0968
11-digit product format
411670968
Labeler code
41167
Product ID
41167-0968_89178b7c-ada6-48bc-9e42-678bbcad2370
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
2011-02-01
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 Dry Mouth Anticavity Mouth
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
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0968-0ACT Total Care Dry Mouth Anticavity Mouth532 mL in 1 BOTTLERINSE53213
41167-0968-3ACT Total Care Dry Mouth Anticavity Mouth1000 mL in 1 BOTTLERINSE100013
41167-0968-5ACT Total Care Dry Mouth Anticavity Mouth88 mL in 1 BOTTLERINSE8813
41167-0968-9ACT Total Care Dry Mouth Anticavity Mouth30 mL in 1 BOTTLERINSE3013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
BETAINEINACTIVE INGREDIENT3SCV180C9WACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
CARNOSINEINACTIVE INGREDIENT8HO6PVN24WACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
GINGERINACTIVE INGREDIENTC5529G5JPQACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
LONICERA JAPONICA FLOWERINACTIVE INGREDIENT4465L2WS4YACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
PUERARIA MONTANA VAR. CHINENSIS ROOTINACTIVE INGREDIENTFQN0D1U235ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SORBITOLINACTIVE INGREDIENT506T60A25RACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0968ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]12Current NDC, Legacy NDC, 4 package rows20241215_06684b82-aaa0-4ca6-8d56-4f9866269000.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044540ACT 0.02 % (fluoride ion 0.009 % ) MouthwashPSN06684b82-aaa0-4ca6-8d56-4f986626900013
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN06684b82-aaa0-4ca6-8d56-4f986626900013
1044540sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]SBD06684b82-aaa0-4ca6-8d56-4f986626900013
313029sodium fluoride 0.2 MG/ML MouthwashSCD06684b82-aaa0-4ca6-8d56-4f986626900013
1044540ACT Braces Care 0.02 % MouthwashSY06684b82-aaa0-4ca6-8d56-4f986626900013
1044540ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) MouthwashSY06684b82-aaa0-4ca6-8d56-4f986626900013
1044540ACT Fluoride Rinse 0.2 MG/ML MouthwashSY06684b82-aaa0-4ca6-8d56-4f986626900013
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY06684b82-aaa0-4ca6-8d56-4f986626900013
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY06684b82-aaa0-4ca6-8d56-4f986626900013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0968-041167096800532 mL in 1 BOTTLE (41167-0968-0) 532 ml2011-02-010000-00-00NoNoCurrent
41167-0968-3411670968031000 mL in 1 BOTTLE (41167-0968-3) 1000 ml2011-02-010000-00-00NoNoCurrent
41167-0968-54116709680588 mL in 1 BOTTLE (41167-0968-5) 88 ml2011-02-010000-00-00NoNoCurrent
41167-0968-94116709680930 mL in 1 BOTTLE (41167-0968-9) 30 ml2011-02-010000-00-00NoNoCurrent