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 34 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dentisse SODIUM FLUORIDE Dentisse, Inc. 326b290a-9bd2-468e-e054-00144ff8d46c 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 51f1d84c-809a-4c96-a117-7a8d8aa1e6b4 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. c44686f8-93ee-4a8f-8481-3439d123f6d2 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 16ebcb37-5703-4e10-b965-570e18434b52 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker GREAT WHITE SHARK SODIUM FLUORIDE YOUNG PS ACQUISITION, LLC ca5b91aa-f69c-4553-a2b6-acf0ca1d920e 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65fa41e-ce2e-53e4-e053-2995a90a24d2 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65c62d9-e8a6-3101-e053-2995a90a1494 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75 2025-11-04 Warnings Exact identifier application number: M021 Strawberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426c2aca-ca2b-5e34-e063-6294a90ae37c 2025-11-02 Warnings Exact identifier application number: M021 Watermelon Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426e40cb-e30d-0db1-e063-6294a90a762b 2025-10-31 Warnings Exact identifier application number: M021 Classic Mint Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425a9b71-5a7f-83e6-e063-6394a90ab703 2025-10-30 Warnings Exact identifier application number: M021 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425b1a2e-7576-13a7-e063-6394a90aa865 2025-10-30 Warnings Exact identifier application number: M021 The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426b8efa-e691-a67d-e063-6394a90abf8d 2025-10-30 Warnings Exact identifier application number: M021 Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 42583b32-525f-925d-e063-6294a90af76f 2025-10-29 Warnings Exact identifier application number: M021 PERIOE KAKAO KIDS Strawberry SODIUM FLUORIDE LG HOUSEHOLD & HEALTH CARE LTD. 4239f8c2-a5f5-3fa6-e063-6294a90acb47 2025-10-28 Warnings Exact identifier application number: M021 Gerigentle-Good morning SODIUM FLORIDE Geri-Gentle Corporation e69b3767-00c5-a535-e053-2995a90ad215 2025-10-23 Warnings Exact identifier application number: M021 Hello Penguin Chill SODIUM FLUORIDE Colgate-Palmolive Company 5c47a7d5-da34-4658-8006-b36f6477cb9b 2025-10-23 Warnings Exact identifier application number: M021 Auraglow Whitening SODIUM FLUORIDE Auraglow LLC 9d45e436-92f6-4a9e-9b82-329847dca9ba 2025-10-22 Warnings Exact identifier application number: M021 COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3 2025-10-21 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Qubec Inc. DBA Attitude de21b326-f885-464b-b2df-f3866a0b3e9a 2025-10-20 Warnings Exact identifier application number: M021
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