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

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 Restoring Anticavity Fluoride Cool Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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
240698Internal RxNorm lookup
656809Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef63e193-5804-4b35-bae7-cad29cf4e8bcAvailable on FDA.report

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

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 2 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
application number: M021

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