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 19 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burts Bees Charcoal PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Companya343853e-4968-2753-e053-2995a90ab1522026-02-02WarningsExact identifier
application number: M021
Burts Bees Complete Multi-CareSODIUM FLUORIDEProcter & Gamble Manufacturing Company12615266-06e8-b891-e063-6394a90ad75d2026-02-02WarningsExact identifier
application number: M021
LIVFRESH GUM PROTECTSTANNOUS FLUORIDELivionex Inc.1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Cars Chow CherrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d66ad5-cdae-52f4-e063-6294a90a8ee92026-02-01WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Brilliant WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4e53a086-6cda-6460-e063-6394a90af1f32026-02-01Exact identifier
application number: M021
ACT Kids Berry BlastSODIUM FLUORIDEChattem, Inc.4f81ea98-5c74-4473-9764-3f11d627cdf12026-02-01WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERite Aid Corporationc1a22692-b955-498a-a7c1-1cd7bfd54bda2026-01-30Warnings, Adverse reactionsExact identifier
application number: M021
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb5eec445-d93a-4abb-a5e3-bfcde6fa20132026-01-28WarningsExact identifier
application number: M021
Supersmile Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc24fee793-57ed-87e9-e063-6394a90ab4ce2026-01-28WarningsExact identifier
application number: M021
Colgate 5g and Toothbrush Dental KitSODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b132026-01-28WarningsExact identifier
application number: M021
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey PunchSODIUM FLUORIDEAshtel Studios Inc.023cb63c-52b4-4723-bff6-c25105a53f762026-01-28WarningsExact identifier
application number: M021
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike StrawberrySODIUM FLUORIDEAshtel Studios, Inc.ef4ea4a3-c1ac-447f-a70b-e3a330928cfd2026-01-27WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATETom's of Maineae6de376-76fd-4609-a2d5-7a902c0d4c5c2026-01-27WarningsExact identifier
application number: M021
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
application number: M021
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
application number: M021
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
application number: M021
Hello Unicorn SplashSODIUM FLUORIDEAccupac LLC23807810-990a-b723-e063-6394a90aee3e2026-01-22WarningsExact 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