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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup
1044540Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06684b82-aaa0-4ca6-8d56-4f9866269000Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen Up chai latte mintSODIUM FLUORIDEMKJ BRANDS LLC52e364f9-113a-df4e-e063-6294a90a263b2026-07-14WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEMKJ BRANDS LLC5257c409-d379-8c48-e063-6294a90acda92026-07-14WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEMKJ BRANDS LLC52bbc6d9-17ab-851a-e063-6394a90ab4bf2026-07-14WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEMKJ BRANDS LLC5259bc45-85da-b17b-e063-6294a90a79192026-07-14WarningsExact identifier
application number: M021
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLESODIUM FLUORIDEColgate-Palmolive Company7f240d1d-ea3d-42b1-a4b0-106c587074522026-07-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
application number: M021
Dr. Noah Kids ToothSODIUM MONOFLUOROPHOSPHATEProject Noah Inc.562311aa-9ac5-00c2-e063-6394a90a67a72026-07-08WarningsExact identifier
application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company263fef13-347b-489b-987d-933a63dbc9002026-07-08WarningsExact identifier
application number: M021
Colgate Triple ActionSODIUM FLUORIDEColgate-Palmolive Company3082e9ba-66d9-4fc7-bbe6-b41b60939bd22026-07-08WarningsExact identifier
application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Companyf464cecb-e876-4057-ab5c-94de747434db2026-07-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560815d6-018a-0c24-e063-6394a90a10712026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ecfbed-ba99-11eb-e063-6294a90ae64d2026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash stripedSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company56091601-74dd-0a3b-e063-6394a90af4762026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55054217-f21b-1c41-e063-6394a90ae40b2026-07-07WarningsExact identifier
application number: M021
Hello Dragon Dazzle Dragon Dazzle FluorideSODIUM FLUORIDEColgate-Palmolive Companyeaca1ad1-9e31-b904-4148-247ad24606612026-07-07WarningsExact identifier
application number: M021
Colgate Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companycdd2ad04-8c65-40f2-b323-5ce11af52e4f2026-07-06WarningsExact identifier
application number: M021
AIM Cavity Protection with WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.a8c742e1-ee61-4593-b8f5-b9e586d39dfc2026-07-01WarningsExact identifier
application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINTSODIUM FLUORIDETom's of Maine6f825520-0f8a-4b4c-bbb6-987f64ab87692026-07-01WarningsExact identifier
application number: M021
Colgate Deep Clean FluorideSODIUM FLUORIDEColgate-Palmolive Company47e8e943-f4d5-40bc-8f79-ec9ea06125de2026-07-01WarningsExact identifier
application number: M021

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