FDA.reportPublic FDA data

COLGATE 2IN1

Product NDC
65954-355
11-digit product format
659540355
Labeler code
65954
Product ID
65954-355_cc23a9fd-854b-4e27-bd22-7c6c0b759291
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
2011-07-26
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COLGATE 2IN1
Brand name suffix
ICY BLAST
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-355-81COLGATE 2IN1ICY BLAST130 g in 1 BOTTLEGEL, DENTIFRICE1306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
MICAINACTIVE INGREDIENTV8A1AW0880COLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-355COLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6Current NDC, Legacy NDC, 1 package rows20241101_23aa663d-338a-49b3-89fe-d79d3299c8b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN23aa663d-338a-49b3-89fe-d79d3299c8b66
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD23aa663d-338a-49b3-89fe-d79d3299c8b66
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY23aa663d-338a-49b3-89fe-d79d3299c8b66
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY23aa663d-338a-49b3-89fe-d79d3299c8b66
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY23aa663d-338a-49b3-89fe-d79d3299c8b66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-355-8165954035581130 g in 1 BOTTLE (65954-355-81) 130 g2016-08-11NoNoCurrent