FDA.reportPublic FDA data

GO SMILE LUXURY

Product NDC
44873-106
Requested package NDC
44873-106-11
11-digit product format
448730106
Labeler code
44873
Product ID
44873-106_f175144c-bee6-5679-e053-2995a90ae3be
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Go Smile, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-27
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage44873-10644873-106-11IInactivated 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 · 9 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44873-106-112025-01-30C16284748780-12cef2736-7ab7-d83d-e063-dadaa90ab31fGOSMILE (as PLD) - LUXURY TOOTHPASTE, AM (44873-106)
44873-106-132025-01-30C16284748780-12cef2736-7ab7-d83d-e063-dadaa90ab31fGOSMILE (as PLD) - LUXURY TOOTHPASTE, AM (44873-106)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44873-106-11GO SMILE LUXURYAM28 g in 1 TUBEPASTE, DENTIFRICE284
44873-106-13GO SMILE LUXURYAM100 g in 1 TUBEPASTE, DENTIFRICE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44873-106GO SMILE LUXURY AM (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [GO SMILE, INC.]4Legacy NDC, 2 package rows20231116_68f24abb-19b0-4dbd-aac0-9fd6dada1531.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN68f24abb-19b0-4dbd-aac0-9fd6dada15314
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD68f24abb-19b0-4dbd-aac0-9fd6dada15314
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY68f24abb-19b0-4dbd-aac0-9fd6dada15314
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY68f24abb-19b0-4dbd-aac0-9fd6dada15314
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY68f24abb-19b0-4dbd-aac0-9fd6dada15314
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY68f24abb-19b0-4dbd-aac0-9fd6dada15314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44873-106-114487301061128 g in 1 TUBE (44873-106-11) 28 g2015-10-270000-00-00NoNoCurrent