Plus White Smokers Whitening

Product NDC
61543-1554
Requested package NDC
61543-1554-3
11-digit product format
615431554
Labeler code
61543
Product ID
61543-1554_0524f242-92ea-4fe0-a8f8-8bbea4df59cc
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
CCA Industries, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-01-31
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage61543-155461543-1554-3IInactivated by FDA2026-10-21

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 · 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
61543-1554-32025-01-30C16284748780-12cef2736-6ab6-d83d-e063-dadaa90ab31fPlus White Smokers Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-1554-3Plus White Smokers Whitening100 g in 1 TUBEPASTE, DENTIFRICE1002
61543-1554-3Plus White Smokers Whitening1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-1554PLUS WHITE SMOKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [CCA INDUSTRIES, INC.]2Legacy NDC, 2 package rows20191227_784ac65d-4604-4399-8645-a8338b25aece.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247591sodium monofluorophosphate 0.83 % (fluoride 0.11 % ) ToothpastePSN784ac65d-4604-4399-8645-a8338b25aece2
1247591sodium monofluorophosphate 0.0083 MG/MG ToothpasteSCD784ac65d-4604-4399-8645-a8338b25aece2
1247591sodium monofluorophosphate 0.83 % ToothpasteSY784ac65d-4604-4399-8645-a8338b25aece2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61543-1554-3615431554031 TUBE in 1 CARTON (61543-1554-3) > 100 g in 1 TUBE1 tube2018-01-310000-00-00NoNoCurrent