Anticavity

Product NDC
72288-439
11-digit product format
722880439
Labeler code
72288
Product ID
72288-439_5ca0c514-66ab-9d5c-e063-6294a90aec4b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Amazon.com Services LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-01
Substance
SODIUM FLUORIDE
Active strength
.2 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72288-43972288-439-45DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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
Anticavity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-439-43Anticavity473 mL in 1 BOTTLE, PLASTICMOUTHWASH47315
72288-439-45Anticavity946 mL in 1 BOTTLE, PLASTICMOUTHWASH94615

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-439ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [AMAZON.COM SERVICES LLC]13Current NDC, Legacy NDC, 2 package rows20250221_4a0220f8-748f-4a4a-9a8b-948756468f82.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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Maximum SecuritySODIUM FLUORIDEBob Barker Company Inc.e29f30ec-72ea-4944-a2c2-b1696d31b6392024-02-27WarningsExact identifier
application number: M021
Made by Dentists For Kids Monster Slime Sour AppleSODIUM FLUORIDEMADE BY DENTISTS INCdfddc67c-3626-48c4-8120-bcc6c455d1192024-02-23WarningsExact identifier
application number: M021
Orajel Gabbys DollhouseSODIUM FLUORIDEChurch & Dwight Co., Inc.cd47bd1e-44ac-465f-8529-6073ade147062024-02-23WarningsExact identifier
application number: M021
Colgate Kids Maximum Cavity ProtectionSODIUM FLUORIDEColgate-Palmolivec44c7a7e-fc3e-a81b-1961-ff89614b678f2024-02-22WarningsExact identifier
application number: M021
TheraBreath Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
application number: M021
Nature Mint AnticavitySODIUM MONOFLUOROPHOSPHATEBob Barker Company Inc.916891d3-5234-46a8-a492-21a31f36a8522024-02-02WarningsExact identifier
application number: M021
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
application number: M021
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98aebbec-aec0-1478-e053-2a95a90a03ea2024-01-30WarningsExact identifier
application number: M021
Toms Childrens Anticavity Mouthwash Silly StrawberrySODIUM FLUORIDETom's of Maine, Inc.998c6f35-20f4-4cb8-bc48-6aa39e61481a2024-01-18WarningsExact identifier
application number: M021
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2b4b6f9a-0e31-4891-8721-d1b9a58cca962024-01-12WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Cool MintSODIUM FLUORIDEColgate-Palmolive Company51abd6bc-7a3d-4b0e-a810-af9e949264382024-01-09WarningsExact identifier
application number: M021
Colgate Enamel Strength MouthwashSODIUM FLUORIDEColgate-Palmolive - do not usef0cca38b-c0a3-4788-8cca-727a5684c16b2024-01-09WarningsExact identifier
application number: M021
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
application number: M021
PerCara Kids Bubble GumSODIUM FLUORIDELEC Custom Products, Inc.be3a7272-acfb-7d14-e053-2995a90a94202024-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4a0220f8-748f-4a4a-9a8b-948756468f8215
313029sodium fluoride 0.2 MG/ML MouthwashSCD4a0220f8-748f-4a4a-9a8b-948756468f8215
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY4a0220f8-748f-4a4a-9a8b-948756468f8215
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4a0220f8-748f-4a4a-9a8b-948756468f8215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-439-4372288043943473 mL in 1 BOTTLE, PLASTIC (72288-439-43) 473 ml2018-05-010000-00-00NoNoCurrent
72288-439-4572288043945946 mL in 1 BOTTLE, PLASTIC (72288-439-45) 946 ml2018-05-010000-00-00NoNoCurrent