ACT Restoring Anticavity Fluoride Cool Splash Spearmint 2X

Product NDC
41167-0980
11-digit product format
411670980
Labeler code
41167
Product ID
41167-0980_455bcc32-1196-4c74-b72e-9db3b8f2c8c6
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
MOUTHWASH
Route
TOPICAL
Labeler
Chattem, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-02-01
Marketing end
2020-05-09
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct41167-0980DDiscontinued by firm2026-08-17
excluded packagepackage41167-098041167-0980-6DDiscontinued by firm2026-08-17

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 packagepackage41167-0980-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41167-0980-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41167-0980-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41167-0980-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41167-0980-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41167-0980-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41167-0980-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41167-0980-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41167-0980-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41167-0980-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41167-0980-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41167-0980-6557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.]2