FDA.reportPublic FDA data

Plaque Refresh Remineralizing Rinse Fresh Mint

Product NDC
57660-003
Requested package NDC
57660-003-01
11-digit product format
576600003
Labeler code
57660
Product ID
57660-003_d8b515d2-5427-06aa-e053-2a95a90aceb9
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
TJA Health LLC
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-01-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage57660-00357660-003-01DDiscontinued by firm2026-10-05

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 · 3 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
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57660-00357660-003-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57660-00357660-003-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57660-00357660-003-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57660-003-012025-02-12C16284748780-12cef2736-ae92-d83d-e063-dadaa90ab31fPlaque Refresh Remineralizing Rinse Fresh Mint
57660-003-012025-01-30C16284748780-12cef2736-ae92-d83d-e063-dadaa90ab31fPlaque Refresh Remineralizing Rinse Fresh Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57660-003-01Plaque Refresh Remineralizing Rinse Fresh Mint473 mL in 1 BOTTLELIQUID4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57660-003PLAQUE REFRESH REMINERALIZING RINSE FRESH MINT (SODIUM FLUORIDE) LIQUID [TJA HEALTH LLC]3Legacy NDC, 1 package rows20250214_bc1f90da-468c-43aa-b639-fb457070f42f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNbc1f90da-468c-43aa-b639-fb457070f42f4
313029sodium fluoride 0.2 MG/ML MouthwashSCDbc1f90da-468c-43aa-b639-fb457070f42f4
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYbc1f90da-468c-43aa-b639-fb457070f42f4
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYbc1f90da-468c-43aa-b639-fb457070f42f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57660-003-0157660000301473 mL in 1 BOTTLE (57660-003-01) 473 ml2022-01-010000-00-00NoNoCurrent