AIM

Product NDC
10237-637
Requested package NDC
10237-637-55
11-digit product format
102370637
Labeler code
10237
Product ID
10237-637_9374c726-ff5d-385d-e053-2995a90ac385
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
2010-11-10
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10237-63710237-637-55DDiscontinued by firm2026-08-11

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
MICAINACTIVE INGREDIENTV8A1AW0880AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5EAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-637-55102370637551 TUBE in 1 CARTON (10237-637-55) > 156 g in 1 TUBE1 tube2019-05-010000-00-00NoNoCurrent