FDA.reportPublic FDA data

Luster Premium White

Product NDC
72805-150
Requested package NDC
72805-150-28
11-digit product format
728050150
Labeler code
72805
Product ID
72805-150_bf1e7c8d-bb4b-481d-b464-f25ebb8f202d
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE
Route
DENTAL
Labeler
French Transit, Ltd.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-04-01
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 g/100g
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 packagepackage72805-15072805-150-28IInactivated by FDA2026-10-05

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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…

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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-01-30Luster Premium White ® Power White Pro™
2020-12-17Luster Premium White ® Power White Pro™
2020-09-27Luster Premium White ® Power White Pro™
2020-09-25Luster Premium White ® Power White Pro™
2020-07-22Luster Premium White ® Power White Pro™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-150-28Luster Premium White Power White Pro28 g in 1 TUBEPASTE283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-150LUSTER PREMIUM WHITE POWER WHITE PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE [FRENCH TRANSIT, LTD.]3Legacy NDC, 1 package rows20220113_6ecbbe6e-17d5-4674-9347-91da8572956c.zip
72805-150LUSTER PREMIUM WHITE PRO LIGHT DENTAL WHITENING SYSTEM (SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]3Legacy NDC20220113_235a44e1-8ef0-4310-9055-7c4eb9c319c2.zip
72805-150LUSTER PREMIUM WHITE PRO SONIC DENTAL WHITENING SYSTEM (SODIUM MONOFLUOROPHOSPHATE) KIT [FRENCH TRANSIT, LTD.]3Legacy NDC20220113_ef2c8cc5-8aea-4ad1-8d5f-645b092e0157.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1546238sodium monofluorophosphate 0.88 % ToothpastePSN235a44e1-8ef0-4310-9055-7c4eb9c319c23
1546238sodium monofluorophosphate 0.88 % ToothpastePSN6ecbbe6e-17d5-4674-9347-91da8572956c3
1546238sodium monofluorophosphate 0.88 % ToothpastePSNef2c8cc5-8aea-4ad1-8d5f-645b092e01573
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCD235a44e1-8ef0-4310-9055-7c4eb9c319c23
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCD6ecbbe6e-17d5-4674-9347-91da8572956c3
1546238sodium monofluorophosphate 0.0088 MG/MG ToothpasteSCDef2c8cc5-8aea-4ad1-8d5f-645b092e01573
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSY235a44e1-8ef0-4310-9055-7c4eb9c319c23
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSY6ecbbe6e-17d5-4674-9347-91da8572956c3
1546238sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )ToothpasteSYef2c8cc5-8aea-4ad1-8d5f-645b092e01573
1546238sodium monofluorophosphate 0.88 % ToothpasteSY235a44e1-8ef0-4310-9055-7c4eb9c319c23
1546238sodium monofluorophosphate 0.88 % ToothpasteSY6ecbbe6e-17d5-4674-9347-91da8572956c3
1546238sodium monofluorophosphate 0.88 % ToothpasteSYef2c8cc5-8aea-4ad1-8d5f-645b092e01573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72805-150-287280501502828 g in 1 TUBE (72805-150-28) 28 g2018-04-010000-00-00NoNoCurrent