Home NDC 41167-0979 ACT Restoring Anticavity Fluoride Mint Burst
Product NDC 41167-0979
11-digit product format 411670979
Labeler code 41167
Product ID 41167-0979_c8d906b9-c4c5-425f-8955-e3b451311e74
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler Chattem, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-12-16
Substance SODIUM FLUORIDE
Active strength .5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 41167-0979 41167-0979-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ACT Restoring Anticavity Fluoride Mint Burst
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240698 Internal RxNorm lookup 656809 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41167-0979-0 ACT Restoring Anticavity Fluoride Mint Burst 532 mL in 1 BOTTLE, PLASTIC MOUTHWASH 532 8 41167-0979-1 ACT Restoring Anticavity Fluoride Mint Burst 30 mL in 1 BOTTLE, PLASTIC MOUTHWASH 30 8 41167-0979-3 ACT Restoring Anticavity Fluoride Mint Burst 88 mL in 1 BOTTLE, PLASTIC MOUTHWASH 88 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41167-0979 ACT RESTORING ANTICAVITY FLUORIDE MINT BURST (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20250214_a38363e6-7105-4663-95a0-09ecb2948f83.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41167-0979-0 41167097900 532 mL in 1 BOTTLE, PLASTIC (41167-0979-0) 532 ml 2015-12-16 0000-00-00 No No Current 41167-0979-1 41167097901 30 mL in 1 BOTTLE, PLASTIC (41167-0979-1) 30 ml 2015-12-16 0000-00-00 No No Current 41167-0979-3 41167097903 88 mL in 1 BOTTLE, PLASTIC (41167-0979-3) 88 ml 2015-12-16 0000-00-00 No No Current