Home NDC 35000-972 Colgate MaxFresh with Whitening KnockOut Fluoride
Product NDC 35000-972
11-digit product format 350000972
Labeler code 35000
Product ID 35000-972_80878d16-ec55-43da-bd7a-37f3b2c7529e
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Colgate-Palmolive Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-05
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
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 Colgate MaxFresh with Whitening KnockOut Fluoride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 37 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE Acuseplanet Inc 3c0e1862-293f-4d23-e063-6294a90a33e1 2025-08-10 Warnings Exact identifier application number: M021 Ipana Wintergreen Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc. 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0 2025-07-28 Warnings Exact identifier application number: M021 Ipana Bucky Beaver Bubble Gum Childrens Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc e7aa2a8d-7140-4718-bf69-917bb50d32c7 2025-07-28 Warnings Exact identifier application number: M021 Dubai Chocolate Flavor ANTICAVITY TOOTHPASTE SuperMouth, LLC. d1615a53-ecfc-49d1-b836-f7643b9d2660 2025-07-24 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. 0c7ede82-3b28-40ae-8dfd-cec58825f938 2025-07-23 Warnings Exact identifier application number: M021 Dubai Chocolate Fluoride Mouthwash ANTICAVITY MOUTHWASH SuperMouth, LLC. ef81a983-64c1-4913-9235-25451f023852 2025-07-23 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. 3409a749-4a1a-4950-8c21-364d1b977af7 2025-07-22 Warnings Exact identifier application number: M021 Act Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 2025-07-22 Warnings Exact identifier application number: M021 Brush Buddies Oral Rinse Sparkle Mint SODIUM FLUORIDE ASHTEL STUDIOS, INC fe2c06fc-6497-4888-877f-1a88e02fad20 2025-07-15 Warnings Exact identifier application number: M021 evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 1620c7fa-2af6-4462-af5d-9e122942788a 2025-07-15 Warnings Exact identifier application number: M021 Dentalclean Green Diamond Alcohol Free Mouthwash SODIUM FLUORIDE 0.05% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 5653aa33-4f0e-46b2-9be0-6219143556ec 2025-07-14 Warnings Exact identifier application number: M021 Colgate Total Gum Protect Fresh Mint STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 570e3bd6-eede-4270-9d78-055aeb2b8c17 2025-07-14 Warnings Exact identifier application number: M021 OraPro Fluoride Anticavity FLUORIDE TOOTHPASTE Protegera, Inc. 93b0181c-e29f-42f4-80f5-366463b68f09 2025-07-10 Warnings Exact identifier application number: M021 Enamur Fluoride AntiCavity Toothpast FLUORIDE TOOTHPAST Protegera, Inc 557ced45-f54e-43d8-aa13-46f75b79367c 2025-07-10 Warnings Exact identifier application number: M021 Super Strawberry STRAWBERRY TOOTHPASTE SuperMouth, LLC. a8c2b68d-d28b-41c0-a383-cc706b25aa1a 2025-07-05 Warnings Exact identifier application number: M021 Super Mint SUPER MINT TOOTHPASTE SuperMouth, LLC. be0915f3-36c4-4200-9d15-704cfbd632b4 2025-07-05 Warnings Exact identifier application number: M021 Super Vanilla VANILLA TOOTHPASTE SuperMouth, LLC. 3ddfe20a-86f1-4566-bb77-82c9749411f6 2025-07-05 Warnings Exact identifier application number: M021 Super Chocolate CHOCOLATE TOOTHPASTE SuperMouth, LLC. 48607622-7c5e-4ddc-8d83-707f26c0553f 2025-07-05 Warnings Exact identifier application number: M021 Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. 13dba3ce-88a8-490c-a906-cfd206d1d290 2025-07-01 Warnings Exact identifier application number: M021 evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. baae4f4a-54ef-472a-9c94-31703435750b 2025-07-01 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35000-972-58 35000097258 1 TUBE in 1 CARTON (35000-972-58) / 70 g in 1 TUBE 1 tube 2016-01-05 0000-00-00 No No Current 35000-972-60 35000097260 1 TUBE in 1 CARTON (35000-972-60) > 170 g in 1 TUBE 1 tube 2016-01-05 0000-00-00 No No Current 35000-972-63 35000097263 1 TUBE in 1 CARTON (35000-972-63) / 178 g in 1 TUBE 1 tube 2022-04-05 0000-00-00 No No Current 35000-972-99 35000097299 1 TUBE in 1 CARTON (35000-972-99) / 54 g in 1 TUBE 1 tube 2024-04-03 No No Current