FDA.reportPublic FDA data

Mastic Dent Whitening

Product NDC
15304-4182
11-digit product format
153044182
Labeler code
15304
Product ID
15304-4182_3bf69e68-a5be-40b4-9f36-668ac750e0cd
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL; ORAL
Labeler
Chia Gi LTD
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-11-22
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct15304-4182IInactivated by FDA2026-10-12
excluded packagepackage15304-418215304-4182-1IInactivated by FDA2026-10-12

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 · 44 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 packagepackage15304-4182-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage15304-4182-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage15304-4182-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage15304-4182-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage15304-4182-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage15304-4182-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage15304-4182-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage15304-4182-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage15304-4182-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage15304-4182-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage15304-4182-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage15304-4182-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage15304-4182-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage15304-4182-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage15304-4182-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage15304-4182-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage15304-4182-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage15304-4182-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage15304-4182-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage15304-4182-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage15304-4182-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15304-4182-1110d247fa046…a55b01930146…

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
15304-4182-12019-11-27C16284748780-19855d018-d4c6-cd31-e053-dbdaa90ab51a9e98b782-111a-4cf0-98b4-774063a12217

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15304-4182-1Mastic Dent Whitening75 mL in 1 TUBEPASTE, DENTIFRICE751

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7MASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
.ALPHA.-BISABOLOL, ()-INACTIVE INGREDIENT36HQN158VCMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
ALLANTOININACTIVE INGREDIENT344S277G0ZMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
CALCIUM PYROPHOSPHATEINACTIVE INGREDIENTX69NU20D19MASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
CAMELLIA SINENSIS SEED OILINACTIVE INGREDIENTO5R6DK2M9KMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
ENOXOLONEINACTIVE INGREDIENTP540XA09DRMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9MASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
PISTACIA LENTISCUS RESININACTIVE INGREDIENT7446H202QWMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS99618MASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
SORBITOLINACTIVE INGREDIENT506T60A25RMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15304-4182MASTIC DENT WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]1Legacy NDC, 1 package rows20121227_9e98b782-111a-4cf0-98b4-774063a12217.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN9e98b782-111a-4cf0-98b4-774063a122171
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD9e98b782-111a-4cf0-98b4-774063a122171
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY9e98b782-111a-4cf0-98b4-774063a122171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
15304-4182-11530441820175 mL in 1 TUBE75 mlHistorical