FDA.reportPublic FDA data

Anticavity

Product NDC
55910-163
11-digit product format
559100163
Labeler code
55910
Product ID
55910-163_4c0f0ffe-bed6-25e9-e063-6294a90a04dd
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Old East Main Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-05-13
Substance
SODIUM FLUORIDE
Active strength
.1 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 packagepackage55910-16355910-163-86DDiscontinued by firm2026-10-21

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-16355910-163-86DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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.1 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
64f3d92d-f58c-4bc2-8819-f91492221ddbAvailable 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
55910-163-85Anticavity250 mL in 1 BOTTLE, PLASTICMOUTHWASH25019
55910-163-86Anticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100019

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
THYMOLINACTIVE INGREDIENT3J50XA376EANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-163ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [OLD EAST MAIN CO.]15Current NDC, Legacy NDC, 2 package rows20240918_64f3d92d-f58c-4bc2-8819-f91492221ddb.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 31 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b68315c-6afa-3f37-e063-6294a90a14e82025-12-11WarningsExact identifier
application number: M021
ANTICAVITY FLUORIDESODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD295b88e8-c4b5-c0b0-e063-6394a90aca012025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74f072-c33b-c6e2-e063-6394a90ab1e62025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba4a807-d6d5-04a0-e063-6294a90ae04d2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b617f4a-b56c-9f75-e063-6294a90a7abe2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b9ec370-eadf-92c4-e063-6294a90a90552025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVORSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1eb04296-ecb1-3ccc-e063-6294a90a9bda2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b9e7b21-0d34-74ec-e063-6294a90a1f592025-12-11Exact identifier
application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLC28986d7f-3e9a-8dfb-e063-6394a90a731e2025-12-10WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATEColgate-Palmolive Company0d6c51bc-5391-4533-b4fd-961dc4f363422025-12-10WarningsExact identifier
application number: M021
Business Class KitSODIUM MONOFLUOROPHOSPHATEAmerican Airlines, Inc.483d7aec-34ac-49c5-ac0e-8fba5b4737ae2025-12-09WarningsExact identifier
application number: M021
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd121decce-c364-4060-87da-0c6a6cd484742025-12-08WarningsExact identifier
application number: M021
First Class KitSODIUM MONOFLUOROPHOSPHATEAmerican Airlines, Inc.ba717de8-c3a2-41bf-85a1-aa75f9744d302025-12-08WarningsExact identifier
application number: M021
United Airlines Business Class KitSODIUM MONOFLUOROPHOSPHATEUnited Airlines94c5e9a4-19f3-4590-9da4-313c752612312025-12-08WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC5f08d994-e458-42b2-aa39-e84fca3acf482025-12-05WarningsExact identifier
application number: M021
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN64f3d92d-f58c-4bc2-8819-f91492221ddb19
313029sodium fluoride 0.2 MG/ML MouthwashSCD64f3d92d-f58c-4bc2-8819-f91492221ddb19
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY64f3d92d-f58c-4bc2-8819-f91492221ddb19
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY64f3d92d-f58c-4bc2-8819-f91492221ddb19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-163-8555910016385250 mL in 1 BOTTLE, PLASTIC (55910-163-85) 250 ml2025-09-09NoNoCurrent
55910-163-86559100163861000 mL in 1 BOTTLE, PLASTIC (55910-163-86) 1000 ml2006-05-130000-00-00NoNoCurrent