Home NDC 41167-0983 ACT Whitening Anticavity Gentle Mint
Product NDC 41167-0983
11-digit product format 411670983
Labeler code 41167
Product ID 41167-0983_e0e0a4a0-368c-4b6c-94bb-0988f3d8cc58
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride 0.02 (0.009 w/v fluoride ion)
Dosage form MOUTHWASH
Route TOPICAL
Labeler Chattem, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-01
Substance SODIUM FLUORIDE
Active strength .09 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Whitening Anticavity Gentle Mint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .09 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 313029 Internal RxNorm lookup 1044540 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 41167-0983-2 ACT Whitening Anticavity Gentle Mint 500 mL in 1 BOTTLE MOUTHWASH 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41167-0983 ACT WHITENING ANTICAVITY GENTLE MINT (SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)) MOUTHWASH [CHATTEM, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240906_cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49.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 5 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 41167-0983-2 41167098302 500 mL in 1 BOTTLE (41167-0983-2) 500 ml 2019-03-01 0000-00-00 No No Current