Home NDC 65954-060 COLGATE Great Regular Flavor
Product NDC 65954-060
11-digit product format 659540060
Labeler code 65954
Product ID 65954-060_fb61fcd5-756d-415c-b718-fa6c1a916179
Type HUMAN OTC DRUG
Nonproprietary name SODIUM MONOFLUOROPHOSPHATE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Mission Hills S.A de C.V
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-11-05
Marketing end 0000-00-00
Substance SODIUM MONOFLUOROPHOSPHATE
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 · 54 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65954-060-01 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-01 COLGATE Great Regular Flavor 28 g in 1 TUBE PASTE, DENTIFRICE 28 13 65954-060-04 COLGATE Great Regular Flavor 4.25 g in 1 POUCH PASTE, DENTIFRICE 4.25 13 65954-060-20 COLGATE Great Regular Flavor 24 g in 1 TUBE PASTE, DENTIFRICE 24 13 65954-060-30 COLGATE Great Regular Flavor 170 g in 1 TUBE PASTE, DENTIFRICE 170 13 65954-060-30 COLGATE Great Regular Flavor 3 in 1 CARTON PASTE, DENTIFRICE 3 13 65954-060-33 COLGATE Great Regular Flavor 36.8 g in 1 TUBE PASTE, DENTIFRICE 36.8 13 65954-060-33 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-46 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-46 COLGATE Great Regular Flavor 130 g in 1 TUBE PASTE, DENTIFRICE 130 13 65954-060-48 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-48 COLGATE Great Regular Flavor 226 g in 1 TUBE PASTE, DENTIFRICE 226 13 65954-060-58 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-58 COLGATE Great Regular Flavor 70 g in 1 TUBE PASTE, DENTIFRICE 70 13 65954-060-60 COLGATE Great Regular Flavor 170 g in 1 TUBE PASTE, DENTIFRICE 170 13 65954-060-64 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-64 COLGATE Great Regular Flavor 181 g in 1 TUBE PASTE, DENTIFRICE 181 13 65954-060-69 COLGATE Great Regular Flavor 113 g in 1 TUBE PASTE, DENTIFRICE 113 13 65954-060-69 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-79 COLGATE Great Regular Flavor 79 g in 1 TUBE PASTE, DENTIFRICE 79 13 65954-060-79 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-82 COLGATE Great Regular Flavor 232 g in 1 TUBE PASTE, DENTIFRICE 232 13 65954-060-82 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-92 COLGATE Great Regular Flavor 1 in 1 CARTON PASTE, DENTIFRICE 1 13 65954-060-92 COLGATE Great Regular Flavor 141 g in 1 TUBE PASTE, DENTIFRICE 141 13 65954-060-93 COLGATE Great Regular Flavor 99 g in 1 TUBE PASTE, DENTIFRICE 99 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM MONOFLUOROPHOSPHATE ACTIVE INGREDIENT C810JCZ56Q COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 FLUORIDE ION ACTIVE MOIETY Q80VPU408O COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 WATER INACTIVE INGREDIENT 059QF0KO0R COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 8 SODIUM MONOFLUOROPHOSPHATE ACTIVE INGREDIENT C810JCZ56Q HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 FLUORIDE ION ACTIVE MOIETY Q80VPU408O HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R HANDY SOLUTIONS COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65954-060 COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V] 13 Legacy NDC, 26 package rows 20250110_0ad8745e-f682-4729-8917-15cb590a1226.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 65954-060-01 65954006001 1 in 1 CARTON Historical 65954-060-04 65954006004 4.25 g in 1 POUCH 4.25 g Historical 65954-060-20 65954006020 24 g in 1 TUBE 24 g Historical 65954-060-30 65954006030 170 g in 1 TUBE 170 g Historical 65954-060-33 65954006033 36.8 g in 1 TUBE 36.8 g Historical 65954-060-46 65954006046 1 in 1 CARTON Historical 65954-060-48 65954006048 1 in 1 CARTON Historical 65954-060-58 65954006058 1 in 1 CARTON Historical 65954-060-60 65954006060 170 g in 1 TUBE 170 g Historical 65954-060-64 65954006064 1 in 1 CARTON Historical 65954-060-69 65954006069 113 g in 1 TUBE 113 g Historical 65954-060-79 65954006079 79 g in 1 TUBE 79 g Historical 65954-060-82 65954006082 232 g in 1 TUBE 232 g Historical 65954-060-92 65954006092 1 in 1 CARTON Historical 65954-060-93 65954006093 99 g in 1 TUBE 99 g Historical