Home NDC 65954-014 Colgate
Product NDC 65954-014
11-digit product format 659540014
Labeler code 65954
Product ID 65954-014_4093df3a-15d5-4455-b9ef-9f70b45257c0
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Mission Hills S.A de C.V
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-08-01
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 1 mg/g
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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.
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 Legacy NDC, 16 package rows 20241127_d142e43f-415a-41c5-a7db-8b18a039a323.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 65954-014-01 65954001401 28.3 g in 1 TUBE 28.3 g Historical 65954-014-58 65954001458 70 g in 1 TUBE 70 g Historical 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 178 g in 1 TUBE 178 g Historical 65954-014-99 65954001499 1 in 1 CARTON Historical