FDA.reportPublic FDA data

Anticavity

Product NDC
55910-030
11-digit product format
559100030
Labeler code
55910
Product ID
55910-030_4c0e8e2a-79a2-8052-e063-6294a90a4786
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
RINSE
Route
ORAL
Labeler
Old East Main Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-24
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 packagepackage55910-03055910-030-44DDiscontinued by firm2026-10-15

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 · 11 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…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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

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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8036e2e-7541-4922-92b9-0d8319f7b64cAvailable 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
55910-030-44Anticavity532 mL in 1 BOTTLE, PLASTICRINSE53227
55910-030-77Anticavity500 mL in 1 BOTTLE, PLASTICRINSE50027

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-030ANTICAVITY (SODIUM FLUORIDE) RINSE [OLD EAST MAIN CO]26Current NDC, Legacy NDC, 2 package rows20250406_f8036e2e-7541-4922-92b9-0d8319f7b64c.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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact identifier
application number: M021
Advance White Tartar Control Breath FresheningSODIUM FLUORIDEChurch & Dwight Co., Inc.aa8be8f5-ba46-4b1b-afaa-58fddf8f87802024-11-20WarningsExact identifier
application number: M021
Enamel DefenseSODIUM FLUORIDEChurch & Dwight Co., Inc.9e8f1ce9-b161-50db-e053-2995a90ad32b2024-11-20WarningsExact identifier
application number: M021
Rembrandt Deeply White Plus PeroxideSODIUM MONOFLUOROPHOSPHATERanir LLCbf7da007-ab9d-4631-bc28-6ca245fd62652024-11-20WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNf8036e2e-7541-4922-92b9-0d8319f7b64c27
240698sodium fluoride 0.5 MG/ML MouthwashSCDf8036e2e-7541-4922-92b9-0d8319f7b64c27
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYf8036e2e-7541-4922-92b9-0d8319f7b64c27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-030-4455910003044532 mL in 1 BOTTLE, PLASTIC532 mlHistorical
55910-030-7755910003077500 mL in 1 BOTTLE, PLASTIC (55910-030-77) 500 ml2015-02-240000-00-00NoNoCurrent