Colgate

Product NDC
35000-430
11-digit product format
350000430
Labeler code
35000
Product ID
35000-430_ec42bbf4-ae00-43cf-841d-abc0651cb68c
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
2024-05-28
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
Brand name suffix
Max Fresh Clean Mint
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-430-58ColgateMax Fresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE13
35000-430-58ColgateMax Fresh Clean Mint70 g in 1 TUBEGEL, DENTIFRICE703
35000-430-95ColgateMax Fresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE13
35000-430-95ColgateMax Fresh Clean Mint179 g in 1 TUBEGEL, DENTIFRICE1793
35000-430-99ColgateMax Fresh Clean Mint53.8 g in 1 TUBE, WITH APPLICATORGEL, DENTIFRICE53.83
35000-430-99ColgateMax Fresh Clean Mint1 in 1 CARTONGEL, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-430COLGATE MAX FRESH CLEAN MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]2Current NDC, 6 package rows20240619_7cb85fc4-573b-45d7-a430-f2fd17320c43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY7cb85fc4-573b-45d7-a430-f2fd17320c433
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY7cb85fc4-573b-45d7-a430-f2fd17320c433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-430-58350000430581 TUBE in 1 CARTON (35000-430-58) / 70 g in 1 TUBE1 tube2024-05-28NoNoHistorical
35000-430-95350000430951 TUBE in 1 CARTON (35000-430-95) / 179 g in 1 TUBE1 tube2024-06-17NoNoHistorical
35000-430-99350000430991 TUBE, WITH APPLICATOR in 1 CARTON (35000-430-99) / 53.8 g in 1 TUBE, WITH APPLICATOR2025-08-01NoNoHistorical