Home NDC 41167-0952-5 ACT Braces Care Anticavity
Product NDC 41167-0952
Requested package NDC 41167-0952-5
11-digit product format 411670952
Labeler code 41167
Product ID 41167-0952_102f0c79-8822-4e22-b90d-a954056745b4
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler Chattem, Inc.
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-02-03
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 0 mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 FLUORIDE ION ACTIVE MOIETY Q80VPU408O ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 CETYLPYRIDINIUM CHLORIDE INACTIVE INGREDIENT D9OM4SK49P ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 EDETATE CALCIUM DISODIUM ANHYDROUS INACTIVE INGREDIENT 8U5D034955 ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 MENTHYL SALICYLATE, (+/-)- INACTIVE INGREDIENT 43XOA705ZD ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SODIUM LAURATE INACTIVE INGREDIENT K146MR5EXO ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SODIUM LAUROYL SARCOSINATE INACTIVE INGREDIENT 632GS99618 ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SODIUM PHOSPHATE INACTIVE INGREDIENT SE337SVY37 ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E ACT BRACES CARE ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41167-0952-5 41167095205 30 mL in 1 BOTTLE, PLASTIC (41167-0952-5) 30 ml 2014-02-03 0000-00-00 No No Current