Business Elite Amenity

Product NDC
52460-003
11-digit product format
524600003
Labeler code
52460
Product ID
52460-003_93c9d2da-2814-2ab7-e053-2995a90a9dff
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-09-16
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct52460-003DDiscontinued by firm2026-10-15
excluded packagepackage52460-00352460-003-01DDiscontinued by firm2026-10-15

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 · 24 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 packagepackage52460-003-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52460-003-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52460-003-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52460-003-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52460-003-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52460-003-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52460-003-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52460-003-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52460-003-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52460-003-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52460-003-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52460-003-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7BUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9BUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
SODIUM ACID PYROPHOSPHATEINACTIVE INGREDIENTH5WVD9LZUDBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
SORBITOLINACTIVE INGREDIENT506T60A25RBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBUSINESS ELITE AMENITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [HANGZHOU ZHUWEN INFLIGHT & TRAVEL PRODUCTS CO., LTD.]1