FDA.reportPublic FDA data

Colgate Max Fresh

Product NDC
35000-899
11-digit product format
350000899
Labeler code
35000
Product ID
35000-899_50be4537-a320-4864-804c-1848e8d5d043
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-16
Substance
SODIUM FLUORIDE
Active strength
2.4 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 Max Fresh
Brand name suffix
Advanced Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
35000-899-34Colgate Max FreshAdvanced Whitening2 in 1 CARTONGEL, DENTIFRICE27
35000-899-34Colgate Max FreshAdvanced Whitening170 g in 1 TUBEGEL, DENTIFRICE1707
35000-899-58Colgate Max FreshAdvanced Whitening70.87 g in 1 TUBEGEL, DENTIFRICE70.877
35000-899-58Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-60Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-60Colgate Max FreshAdvanced Whitening170 g in 1 TUBEGEL, DENTIFRICE1707
35000-899-78Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-78Colgate Max FreshAdvanced Whitening70.8 g in 1 TUBEGEL, DENTIFRICE70.87
35000-899-95Colgate Max FreshAdvanced Whitening1 in 1 CARTONGEL, DENTIFRICE17
35000-899-95Colgate Max FreshAdvanced Whitening178 g in 1 TUBEGEL, DENTIFRICE1787

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-899COLGATE MAX FRESH ADVANCED WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]6Current NDC, Legacy NDC, 10 package rows20250110_01c07c25-2748-4d90-9505-094e2c977c9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY01c07c25-2748-4d90-9505-094e2c977c9c7
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY01c07c25-2748-4d90-9505-094e2c977c9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-899-34350000899342 TUBE in 1 CARTON (35000-899-34) > 170 g in 1 TUBE2 tube2021-10-160000-00-00NoNoCurrent
35000-899-583500008995870.87 g in 1 TUBE70.87 gHistorical
35000-899-60350000899601 TUBE in 1 CARTON (35000-899-60) > 170 g in 1 TUBE1 tube2021-10-160000-00-00NoNoCurrent
35000-899-78350000899781 TUBE in 1 CARTON (35000-899-78) / 70.8 g in 1 TUBE1 tube2024-01-01NoNoCurrent
35000-899-95350000899951 TUBE in 1 CARTON (35000-899-95) / 178 g in 1 TUBE1 tube2021-10-160000-00-00NoNoCurrent