FDA.reportPublic FDA data

ACT Whitening Anticavity Gentle Mint

Product NDC
41167-0983
11-digit product format
411670983
Labeler code
41167
Product ID
41167-0983_e0e0a4a0-368c-4b6c-94bb-0988f3d8cc58
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride 0.02 (0.009 w/v fluoride ion)
Dosage form
MOUTHWASH
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-01
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 Whitening Anticavity Gentle Mint
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
cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49Available 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
41167-0983-2ACT Whitening Anticavity Gentle Mint500 mL in 1 BOTTLEMOUTHWASH5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0983ACT WHITENING ANTICAVITY GENTLE MINT (SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)) MOUTHWASH [CHATTEM, INC.]4Current NDC, Legacy NDC, 1 package rows20240906_cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49.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 46 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Blue Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1881658c-e371-5513-e063-6394a90a465f2024-05-15WarningsExact identifier
application number: M021
Dentalclean Dr. Duck Strawberry flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1882c82a-3a32-5656-e063-6394a90ae0ed2024-05-15WarningsExact identifier
application number: M021
Dentalclean Booster KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186ecaeb-9401-9315-e063-6394a90a8e202024-05-14WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA ATTITUDEfefc1060-e1a4-4686-a8d8-84bf1e613abe2024-05-14WarningsExact identifier
application number: M021
Dentalclean Doctor DuckSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186f2f12-279f-32df-e063-6394a90ad53d2024-05-14WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f31b5e-dd3b-78df-e063-6294a90a43ab2024-05-08WarningsExact identifier
application number: M021
Dentalclean Dental Gel Booster Adult UseSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f3981f-ab4b-0dcd-e063-6294a90a37d92024-05-08WarningsExact identifier
application number: M021
Dentalclean Sensitive PlusSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e0dc93-97bf-7f05-e063-6294a90a9a8b2024-05-07WarningsExact identifier
application number: M021
Dentalclean Whitening MaxSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e2364e-2511-3021-e063-6294a90a40e12024-05-07WarningsExact identifier
application number: M021
DeCureSODIUM MONOFLUOROPHOSPHATEScope medical devices private limited590c4827-f036-45bd-af30-0a4853ca34472024-05-07WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf2024-04-22WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db2024-04-19WarningsExact identifier
application number: M021
Toothpaste, plus ToothbrushSODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSHLil' Drug Store Products, Inc.15ac00f8-da51-6cea-e063-6294a90aeb812024-04-09WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDELG H&H Co.,Ltd.14ea1776-ef7f-27a9-e063-6394a90afd492024-03-29WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.14eb9f74-e5f5-e199-e063-6394a90adbf62024-03-29WarningsExact identifier
application number: M021
Dentalclean Ultra Refreshing Extreme Ice Dental GelSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1496636d-6563-d474-e063-6394a90ab73d2024-03-26WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company142bffe1-1e8c-8567-e063-6394a90af15a2024-03-21WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.13907bf6-9a95-c0b2-e063-6394a90a40422024-03-13WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.13910b55-9b5d-af53-e063-6294a90acf5d2024-03-13WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitudee3bb60f8-2a06-42d6-a182-8c31bb982a2a2024-03-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044540ACT 0.02 % (fluoride ion 0.009 % ) MouthwashPSNcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
1044540sodium fluoride 0.2 MG/ML Mouthwash [ACT Fluoride Rinse]SBDcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
313029sodium fluoride 0.2 MG/ML MouthwashSCDcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
1044540ACT Braces Care 0.02 % MouthwashSYcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
1044540ACT Fluoride Rinse 0.02 % (fluoride ion 0.009 % ) MouthwashSYcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
1044540ACT Fluoride Rinse 0.2 MG/ML MouthwashSYcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYcd45a0b8-9ab3-4aed-8214-a6dcc4cdaf495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0983-241167098302500 mL in 1 BOTTLE (41167-0983-2) 500 ml2019-03-010000-00-00NoNoCurrent