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 49 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact 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