ACT Total Care Sensitive Anticavity Mint Mouth

Product NDC
41167-0964
Requested package NDC
41167-0964-1
11-digit product format
411670964
Labeler code
41167
Product ID
41167-0964_896cb3b3-fbc2-4c3e-a62b-34a285682f1c
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
TOPICAL
Labeler
Chattem, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage41167-096441167-0964-1DDiscontinued 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 · 10 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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 TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
ANGELICA SINENSIS ROOTINACTIVE INGREDIENTB66F4574UGACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
BETAINEINACTIVE INGREDIENT3SCV180C9WACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
CARNOSINEINACTIVE INGREDIENT8HO6PVN24WACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
GINGERINACTIVE INGREDIENTC5529G5JPQACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
LONICERA JAPONICA FLOWERINACTIVE INGREDIENT4465L2WS4YACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
POLYETHYLENE GLYCOL 600000INACTIVE INGREDIENT2126FD486LACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
POLYETHYLENE GLYCOL 7000000INACTIVE INGREDIENTG3MS6M810YACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
PUERARIA MONTANA VAR. LOBATA ROOTINACTIVE INGREDIENTPET93F4I3CACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EACT TOTAL CARE SENSITIVE ANTICAVITY MINT MOUTH (SODIUM FLUORIDE) RINSE [CHATTEM, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0964-141167096401532 mL in 1 BOTTLE (41167-0964-1) 532 ml2012-01-010000-00-00NoNoCurrent