Colgate MaxFresh Charcoal

Product NDC
35000-213
11-digit product format
350000213
Labeler code
35000
Product ID
35000-213_e162e8b0-93d2-49d0-b6eb-b70ec056a113
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
2025-02-03
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 MaxFresh Charcoal
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-213-95Colgate MaxFresh Charcoal178 g in 1 TUBEGEL, DENTIFRICE1781
35000-213-95Colgate MaxFresh Charcoal1 in 1 CARTONGEL, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-213COLGATE MAXFRESH CHARCOAL (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 2 package rows20250204_de3674f4-3ce6-47d5-8391-6ad6789d68d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNde3674f4-3ce6-47d5-8391-6ad6789d68d91
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDde3674f4-3ce6-47d5-8391-6ad6789d68d91
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYde3674f4-3ce6-47d5-8391-6ad6789d68d91
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYde3674f4-3ce6-47d5-8391-6ad6789d68d91
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYde3674f4-3ce6-47d5-8391-6ad6789d68d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-213-95350000213951 TUBE in 1 CARTON (35000-213-95) / 178 g in 1 TUBE1 tube2025-02-03NoNoCurrent