Plus White With Peroxide

Product NDC
61543-7233
11-digit product format
615437233
Labeler code
61543
Product ID
61543-7233_b000b6d8-f927-6cd8-e053-2a95a90a42f5
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE
Route
DENTAL
Labeler
CCA Industries, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-06-09
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 productproduct61543-7233IInactivated by FDA2026-10-05
excluded packagepackage61543-723361543-7233-2IInactivated 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 packagepackage61543-7233-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61543-7233-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61543-7233-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61543-7233-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61543-7233-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61543-7233-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61543-7233-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61543-7233-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61543-7233-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61543-7233-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61543-7233-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61543-7233-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61543-7233-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61543-7233-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61543-7233-21332a3947898…d4bfe170f9cd…

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
61543-7233-22024-01-30C16284748780-1ab0e2407-2ad9-f274-e053-dbdaa90a6471Plus White With Peroxide
61543-7233-22020-09-23C16284748780-1ab0e2407-2ad9-f274-e053-dbdaa90a6471Plus White With Peroxide
61543-7233-22020-07-22C16284748780-1ab0e2407-2ad9-f274-e053-dbdaa90a6471Plus White With Peroxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-7233-2Plus White With Peroxide1 in 1 BOXPASTE14
61543-7233-2Plus White With Peroxide100 g in 1 TUBEPASTE1004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37PLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
CALCIUM PEROXIDEINACTIVE INGREDIENT7FRO2ENO91PLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1
UREAINACTIVE INGREDIENT8W8T17847WPLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-7233PLUS WHITE WITH PEROXIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]4Legacy NDC, 2 package rows20200924_8cee9e75-78c0-4af0-89f5-2ddb88ad6a78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891795sodium monofluorophosphate 0.884 % ToothpastePSN8cee9e75-78c0-4af0-89f5-2ddb88ad6a784
891795sodium monofluorophosphate 0.00884 MG/MG ToothpasteSCD8cee9e75-78c0-4af0-89f5-2ddb88ad6a784
891795sodium monofluorophosphate 0.884 % ToothpasteSY8cee9e75-78c0-4af0-89f5-2ddb88ad6a784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61543-7233-2615437233021 TUBE in 1 BOX (61543-7233-2) > 100 g in 1 TUBE1 tube2019-03-150000-00-00NoNoCurrent