ACT Dry Mouth Anticavity Fluoride

Product NDC
41167-0920
11-digit product format
411670920
Labeler code
41167
Product ID
41167-0920_c433259d-b8dc-4a07-ab60-2fdfb65235c3
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Chattem, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-02-02
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41167-0920DDiscontinued by firm2026-10-05
excluded packagepackage41167-092041167-0920-0DDiscontinued by firm2026-10-05
excluded packagepackage41167-092041167-0920-4DDiscontinued 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 packagepackage41167-0920-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41167-0920-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41167-0920-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41167-0920-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41167-0920-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41167-0920-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41167-0920-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41167-0920-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41167-0920-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41167-0920-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41167-0920-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41167-0920-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41167-0920-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41167-0920-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41167-0920-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41167-0920-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41167-0920-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41167-0920-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41167-0920-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41167-0920-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41167-0920-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41167-0920-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41167-0920-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41167-0920-0557ba5c1ecfa…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 INGREDIENT8ZYQ1474W7ACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
4-TERT-BUTYLCYCLOHEXANOLINACTIVE INGREDIENTK0H1405S9CACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9ACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EACT DRY MOUTH ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHATTEM, INC.]2