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Product NDC
10237-645
11-digit product format
102370645
Labeler code
10237
Product ID
10237-645_81fe3249-dd7c-40e6-9561-e8a76f51f192
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-10-26
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10237-645DDiscontinued by firm2026-08-10
excluded packagepackage10237-64510237-645-40DDiscontinued by firm2026-08-10
excluded packagepackage10237-64510237-645-48DDiscontinued by firm2026-08-10
excluded packagepackage10237-64510237-645-60DDiscontinued by firm2026-08-10

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, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0510237-645-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0510237-645-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0510237-645-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2610237-645-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2610237-645-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2610237-645-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3110237-645-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3110237-645-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3110237-645-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2810237-645-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2810237-645-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2810237-645-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2110237-645-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2110237-645-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2110237-645-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1010237-645-48cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1010237-645-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1010237-645-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3110237-645-48302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3110237-645-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3110237-645-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2010237-645-48ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2010237-645-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2010237-645-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1010237-645-480efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1010237-645-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1010237-645-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0810237-645-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0310237-645-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0910237-645-60557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
MICAINACTIVE INGREDIENTV8A1AW0880CLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-645CLOSE UP WHITENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]10Legacy NDC20241123_ef70424c-d75c-49f9-8161-3cc5af7b0f13.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-645-40102370645401 TUBE in 1 CARTON (10237-645-40) > 113.4 g in 1 TUBE1 tube2010-10-260000-00-00NoNoCurrent
10237-645-48102370645481 TUBE in 1 CARTON (10237-645-48) > 136 g in 1 TUBE1 tube2010-10-260000-00-00NoNoCurrent
10237-645-60102370645601 TUBE in 1 CARTON (10237-645-60) > 170 g in 1 TUBE1 tube2010-10-262021-12-18NoNoCurrent