Crest

Product NDC
69491-831
11-digit product format
694910831
Labeler code
69491
Product ID
69491-831_9ab12d8a-6144-5a7d-e053-2995a90a7c80
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Buzz Export Services Pty., Ltd.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-12-23
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct69491-831DDiscontinued by firm2026-10-05
excluded packagepackage69491-83169491-831-01DDiscontinued by firm2026-10-05

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 · 36 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 packagepackage69491-831-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69491-831-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69491-831-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69491-831-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69491-831-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69491-831-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69491-831-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69491-831-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69491-831-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69491-831-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69491-831-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69491-831-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69491-831-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69491-831-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69491-831-011332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69491-831-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69491-831-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69491-831-019bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7CREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
MICAINACTIVE INGREDIENTV8A1AW0880CREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
POLYETHYLENE OXIDE 900000INACTIVE INGREDIENT16P9295IILCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
SODIUM LAURETH-2 PHOSPHATEINACTIVE INGREDIENT1IO8CC3XDGCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
SORBITOLINACTIVE INGREDIENT506T60A25RCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RCREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ECREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-831CREST (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUZZ EXPORT SERVICES PTY., LTD.]4Legacy NDC20211228_e05b59e4-6b4b-4c8d-965a-d5aa00345a08.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69491-831-01694910831011 TUBE in 1 CARTON (69491-831-01) > 24 g in 1 TUBE1 tube2014-12-230000-00-00NoNoCurrent