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 10 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Frida Fluoride Sweet Mint SODIUM FLUORIDE Fridababy, LLC 4f8b5a39-5d79-72cd-e063-6394a90a475c 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Bubble Mint SODIUM FLUORIDE Fridababy, LLC 4f8b9af3-e4b3-b5e0-e063-6394a90a1068 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry Toothbrush Set SODIUM FLUORIDE Fridababy, LLC 4f8ba14f-60ea-c2a8-e063-6394a90a7702 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry SODIUM FLUORIDE Fridababy, LLC 4f814a62-8f91-8ea6-e063-6294a90a69eb 2026-05-06 Warnings Exact identifier application number: M021 Gum Health Detoxify STANNOUS FLUORIDE Meijer, Inc 41d70733-a223-40fb-e063-6294a90a1397 2026-05-06 Warnings Exact identifier application number: M021 Colgate Kids Unicorn Alcohol Free SODIUM FLUORIDE Colgate-Palmolive Company 133acaff-7205-80d7-e91d-3eb37087cae4 2026-05-05 Warnings Exact identifier application number: M021 Crest 3D White Stain Eraser SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. fdefffbd-9c05-fa30-e053-6394a90a34bc 2026-05-05 Warnings Exact identifier application number: M021 Frida Fluoride Watermelon SODIUM FLUORIDE Fridababy, LLC 4f8b49dc-e9e4-c341-e063-6294a90adb5a 2026-05-05 Warnings Exact identifier application number: M021 White Glo Extreme White Whitening SODIUM MONOFLUOROPHOSPHATE White Glo USA Inc 4a2e0a8d-420e-4c07-aa43-386d05dab472 2026-04-30 Warnings Exact identifier application number: M021 Equate Pro-Advanced TP Equate Pro-Advanced TP STANNOUS FLUORIDE Walmart Inc. 1e6561fb-4e3b-40ba-e063-6294a90a2690 2026-04-29 Warnings Exact identifier application number: M021 Crest Cavity Protection Regular SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. 852889b4-59ba-4592-b4fc-c0127a1ad075 2026-04-28 Warnings Exact identifier application number: M021 Crest Complete Multi-Benefit Whitening plus Scope SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. 0206710a-707f-4aa9-96b9-86240c1275dc 2026-04-28 Warnings Exact identifier application number: M021 Alcohol Free Refreshing Mint SODIUM FLUORIDE H E B cedf7c08-7412-4733-9b67-225b331cec8c 2026-04-27 Warnings, Adverse reactions Exact identifier application number: M021 anzoon ANTIBACTERIAL MOUTH WASH CETYLPYRIDINIUM CHLORIDE Shandong AZC Biotechnology Co.,Ltd. 507c6896-2806-790c-e063-6394a90ac5ce 2026-04-27 Warnings Exact identifier application number: M021 DELTA COMFORT PLUS AMENITY SODIUM MONOFLUOROPHOSPHATE Buzz Products Inc. 26434794-ae02-0f58-e063-6294a90ad85e 2026-04-24 Warnings Exact identifier application number: M021 A and H Plus Therabreath Breath Freshners SODIUM FLUORIDE Church & Dwight Co., Inc. 18d6073e-b1ee-47d2-9758-2cf04f3cf3ca 2026-04-23 Warnings Exact identifier application number: M021 Fluoride SODIUM FLUORIDE McKesson 5025e58e-e59c-07b6-e063-6394a90ac1e8 2026-04-23 Warnings Exact identifier application number: M021 PRO-SYS SENSITIVITY - MINT (OTC) Benco Dental 4e46847e-8c1d-c988-e063-6394a90a8e50 2026-04-22 Warnings Exact identifier application number: M021 Anticavity Fluoride Rinse SODIUM FLUORIDE H E B 87327a36-a314-4daa-83b6-b4bd3e26bba2 2026-04-22 Warnings, Adverse reactions Exact identifier application number: M021 Anticavity SODIUM FLUORIDE H E B 8df324a7-9204-40f3-8ddb-1656286d7d4e 2026-04-22 Warnings, Adverse reactions 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