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 29 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Supersmile Professional Whitening TP Citrus Blast SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 25039552-c35d-a69d-e063-6394a90ab103 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Citrus Blast SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 2504686d-b053-51d0-e063-6394a90a789f 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Peppy Mint 8 oz SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 25121ebb-922b-719d-e063-6394a90a23d3 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro-health Gum Detoxify Deep Clean STANNOUS FLUORIDE The Procter & Gamble Manufacturing Company f498b727-c38c-1d67-e053-2995a90a0f11 2026-01-08 Warnings Exact identifier application number: M021 DG health Sensitive Maximum Strength POTASSIUM NITRATE, SODIUM FLUORIDE Dolgencorp, LLC 81cd5d37-3751-625f-e053-2a91aa0a6dfd 2026-01-08 Warnings Exact identifier application number: M021 Crest 3D White Advanced Glamorous White SODIUM FLUORIDE The Procter & Gamble Manufacturing Company f5b18988-68c7-40f9-e053-2995a90a22bc 2026-01-08 Warnings Exact identifier application number: M021 CVS Restore and Defend Sensitive Whitening STANNOUS FLUORIDE CVS Pharmacy 81b72da2-7f41-74ca-e053-2a91aa0a9646 2026-01-08 Warnings Exact identifier application number: M021 Gum and Enamel Repair STANNOUS FLUORIDE CVS ccad05d4-7f05-bebd-e053-2a95a90aa52c 2026-01-08 Warnings Exact identifier application number: M021 CVS Pharmacy Pro Defense FLUORIDE CVS Pharmacy 445ec57e-dc3c-49a0-8ca9-4806fcdc0303 2026-01-08 Warnings Exact identifier application number: M021 Gum Detoxify STANNOUS FLUORIDE Walmart ad3f645d-aaf9-2800-e053-2a95a90ab62f 2026-01-08 Warnings Exact identifier application number: M021 CVS Complete Protection STANNOUS FLOURIDE CVS b681b5e4-a0e1-8d0f-e053-2a95a90aa672 2026-01-06 Warnings Exact identifier application number: M021 Complete Protection STANNOUS FLUORIDE Target 03708e08-0189-b83d-e063-6394a90a50e6 2026-01-06 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash 12oz Star Wars Saber Strike Strawberry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 4998c0e6-1de3-11cd-e063-6294a90acb6f 2026-01-01 Warnings Exact identifier application number: M021 Exceed Total Care Sensitive Spearmint Tooth Polish POTASSIUM NITRATE AND SODIUM FLUORIDE Melaleuca, Inc dc620d3f-880f-df05-e053-2995a90a8409 2025-12-31 Warnings Exact identifier application number: M021 Exceed Total Care Sensitive Peppermint Tooth Polish POTASSIUM NITRATE AND SODIUM FLUORIDE Melaleuca, Inc ed2179a4-3d19-6481-e053-2995a90ad655 2025-12-31 Warnings Exact identifier application number: M021 Koala Pals Berrylicious SODIUM FLUORIDE Melaleuca, Inc. 6624be86-c9a8-53b8-e053-2a91aa0a87ef 2025-12-31 Warnings Exact identifier application number: M021 Whitening Tooth Polish SODIUM FLUORIDE Melaleuca, Inc. 6893405a-a2c4-068e-e053-2a91aa0ae5b1 2025-12-31 Warnings Exact identifier application number: M021 Gel 1100 Mint SODIUM FLUORIDE Dental Alliance Holdings LLC f125fb04-5045-5367-e053-2a95a90aa73b 2025-12-29 Warnings Exact identifier application number: M021 Gracie Square Hospital Amenity SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 89d81053-6950-465e-a5b1-cbf841d7afcb 2025-12-29 Warnings Exact identifier application number: M021 CloSYS Fluoride Rinse SODIUM FLUORIDE Rowpar Pharmaceuticals, Inc. 1a994f24-99ee-4b27-aab0-e816931a22c8 2025-12-23 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