Plus White Coffee Drinkers Whitening

Product NDC
61543-7224
11-digit product format
615437224
Labeler code
61543
Product ID
61543-7224_b0005220-427b-98f6-e053-2995a90adea0
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
CCA Industries, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-06-12
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61543-7224IInactivated by FDA2026-10-05
excluded packagepackage61543-722461543-7224-3IInactivated 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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61543-7224-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61543-7224-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61543-7224-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61543-7224-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61543-7224-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61543-7224-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61543-7224-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61543-7224-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61543-7224-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61543-7224-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61543-7224-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61543-7224-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61543-7224-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61543-7224-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61543-7224-31332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-7224-3Plus White Coffee Drinkers Whitening1 in 1 PACKAGEPASTE14
61543-7224-3Plus White Coffee Drinkers Whitening100 g in 1 PACKAGEPASTE1004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37PLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-7224PLUS WHITE COFFEE DRINKERS WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]4Legacy NDC, 2 package rows20200924_3687ebb3-be4a-4e46-8f1d-dcf56fddcdfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891795sodium monofluorophosphate 0.884 % ToothpastePSN3687ebb3-be4a-4e46-8f1d-dcf56fddcdfa4
891795sodium monofluorophosphate 0.00884 MG/MG ToothpasteSCD3687ebb3-be4a-4e46-8f1d-dcf56fddcdfa4
891795sodium monofluorophosphate 0.884 % ToothpasteSY3687ebb3-be4a-4e46-8f1d-dcf56fddcdfa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61543-7224-3615437224031 PACKAGE in 1 PACKAGE (61543-7224-3) > 100 g in 1 PACKAGE1 package2010-06-120000-00-00NoNoCurrent