Denti Whoo CTS Gum CareToothpaste

Product NDC
86157-0005
Requested package NDC
86157-0005-1
11-digit product format
861570005
Labeler code
86157
Product ID
86157-0005_dbf978f9-4c0d-7059-e053-2a95a90ad0d9
Type
HUMAN OTC DRUG
Nonproprietary name
Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
SUN LIFE SCIENCE CO LTD
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-04-06
Marketing end
0000-00-00
Substance
.ALPHA.-TOCOPHEROL ACETATE; SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE
Active strength
0 g/100g; g/100g; 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 packagepackage86157-000586157-0005-1IInactivated 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 · 16 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 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…

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
86157-0005-12023-07-28C16284748780-10191ceaa-6d26-198a-e063-dbdaa90aec3edbf979ee-24b9-3d67-e053-2a95a90a429a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86157-0005-1Denti Whoo CTS Gum CareToothpaste50 g in 1 TUBEPASTE, DENTIFRICE502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86157-0005DENTI WHOO CTS GUM CARETOOTHPASTE (SILICON DIOXIDE, SODIUM FLUORIDE, TOCOPHEROL ACETATE) PASTE, DENTIFRICE [SUN LIFE SCIENCE CO LTD]2Legacy NDC, 1 package rows20230303_dbf979ee-24b9-3d67-e053-2a95a90a429a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
86157-0005-18615700050150 g in 1 TUBE (86157-0005-1) 50 g2022-04-060000-00-00NoNoCurrent