Home NDC 65954-014 Colgate
Product NDC 65954-014
11-digit product format 659540014
Labeler code 65954
Product ID 65954-014_6f04db7b-c705-4038-8a35-cd8a62b4bd81
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Mission Hills S.A de C.V
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-08-01
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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
Brand name suffix Max Fresh Cool Mint
Listing expiration 2026-12-31 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65954-014-01 ColgateMax Fresh Cool Mint 28.3 g in 1 TUBE GEL, DENTIFRICE 28.3 16 65954-014-01 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-58 ColgateMax Fresh Cool Mint 70 g in 1 TUBE GEL, DENTIFRICE 70 16 65954-014-58 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-60 ColgateMax Fresh Cool Mint 170 g in 1 TUBE GEL, DENTIFRICE 170 16 65954-014-60 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-63 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-63 ColgateMax Fresh Cool Mint 178 g in 1 TUBE GEL, DENTIFRICE 178 16 65954-014-75 ColgateMax Fresh Cool Mint 79 g in 1 TUBE GEL, DENTIFRICE 79 16 65954-014-75 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-78 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-78 ColgateMax Fresh Cool Mint 221 g in 1 TUBE GEL, DENTIFRICE 221 16 65954-014-95 ColgateMax Fresh Cool Mint 178 g in 1 TUBE GEL, DENTIFRICE 178 16 65954-014-95 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-99 ColgateMax Fresh Cool Mint 1 in 1 CARTON GEL, DENTIFRICE 1 16 65954-014-99 ColgateMax Fresh Cool Mint 53 g in 1 TUBE GEL, DENTIFRICE 53 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 FLUORIDE ION ACTIVE MOIETY Q80VPU408O COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6 WATER INACTIVE INGREDIENT 059QF0KO0R COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65954-014 COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V] 16 Current NDC, Legacy NDC, 16 package rows 20241127_d142e43f-415a-41c5-a7db-8b18a039a323.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 3 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SprinJene White Boost SODIUM FLUORIDE Health and Natural Beauty USA Corp 8c401bea-0148-46a0-bbb3-80c17f9e8e3e 2026-08-14 Warnings Exact identifier application number: M021 ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company 2b123d70-4f7d-41b0-b48f-711999e97ee0 2026-08-13 Warnings Exact identifier application number: M021 COLGATE STRAWBERRY BURST SODIUM FLUORIDE Colgate-Palmolive Company d037f65c-3d22-4d2a-a0a9-3dcba2357ebd 2026-08-13 Warnings Exact identifier application number: M021 COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company cd954777-697a-4cc7-8f5f-b2caf357ef95 2026-08-13 Warnings Exact identifier application number: M021 TOMS OF MAINE KIDS SILLY STRAWBERRY SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. e36ceb7a-9a29-41d8-8d08-a859e515f1f5 2026-08-13 Warnings Exact identifier application number: M021 TOMS OF MAINE WHOLE CARE SPEARMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 08d7ed04-67a4-437a-82c5-496f9893c6c7 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED FRESH COOL PEPPERMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 27278b02-c4fd-4092-a632-a14e442f5a95 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED FRESH SPEARMINT ICE SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 59a6b9ac-c28b-4ec3-8231-f35054ce0eaf 2026-08-10 Warnings Exact identifier application number: M021 Toms Kids Watermelon Wiggle SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids bubblegum SODIUM FLUORIDE Lander Enterprises, LLC 64b60e74-fceb-4de9-a966-73bf8dbd666c 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids strawberry SODIUM FLUORIDE Lander Enterprises, LLC 7e880d50-8aab-4d57-abc1-e900070f9a11 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids watermelon SODIUM FLUORIDE Lander Enterprises, LLC 5cb5eb46-705c-4bb7-bef1-e93a598636fd 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush Mint SODIUM FLUORIDE Lander Enterprises, LLC 0e043431-9d87-478d-87f5-5aa8b0a932eb 2026-08-10 Warnings Exact identifier application number: M021 Willo Minty Mist Dye Free SODIUM FLUORIDE Willo 32, Inc. 3ee5b49e-ca9a-ece6-e063-6394a90a3d00 2026-08-10 Warnings Exact identifier application number: M021 Willo Bubble Twist SODIUM FLUORIDE Willo 32 Inc 36560d62-e901-1f93-e063-6394a90a2803 2026-08-10 Warnings Exact identifier application number: M021 Willo Berry Splash Dye Free SODIUM FLUORIDE Willo 32, Inc 3ea91af9-2895-e530-e063-6394a90a39e5 2026-08-10 Warnings Exact identifier application number: M021 Fluoride Mouth Rinse Anticavity SODIUM FLUORIDE Target Corporation 3daf3cc3-585a-4bb2-9b56-7117d220ed38 2026-08-10 Warnings, Adverse reactions Exact identifier application number: M021 TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 19de1e71-ab94-415f-b66d-e5748dea8317 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WHOLE CARE WINTERMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. d5e1396e-0253-4ec0-a9ff-b61bda70de35 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED COOL MILD MINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. de92408c-d401-47c3-94ee-fb6c08092651 2026-08-10 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 Sample Exclude flag Status 65954-014-01 65954001401 1 TUBE in 1 CARTON (65954-014-01) / 28.3 g in 1 TUBE 1 tube 2011-08-01 No No Current 65954-014-58 65954001458 1 TUBE in 1 CARTON (65954-014-58) / 70 g in 1 TUBE 1 tube 2011-08-01 No No Current 65954-014-60 65954001460 170 g in 1 TUBE 170 g Historical 65954-014-63 65954001463 1 in 1 CARTON Historical 65954-014-75 65954001475 79 g in 1 TUBE 79 g Historical 65954-014-78 65954001478 1 in 1 CARTON Historical 65954-014-95 65954001495 1 TUBE in 1 CARTON (65954-014-95) / 178 g in 1 TUBE 1 tube 2024-05-28 No No Current 65954-014-99 65954001499 1 TUBE in 1 CARTON (65954-014-99) / 53 g in 1 TUBE 1 tube 2011-08-01 No No Current