FDA.reportPublic FDA data

TP COL OW Purple

Product NDC
35000-419
11-digit product format
350000419
Labeler code
35000
Product ID
35000-419_ae66dc76-b3b4-498a-9e8b-cf5fa1127dd5
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
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
TP COL OW Purple
Listing expiration
2026-12-31

Active Ingredients#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-419-58TP COL OW Purple70.8 g in 1 TUBEPASTE, DENTIFRICE70.84
35000-419-58TP COL OW Purple1 in 1 CARTONPASTE, DENTIFRICE14
35000-419-71TP COL OW Purple119 g in 1 TUBEPASTE, DENTIFRICE1194
35000-419-71TP COL OW Purple1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-419TP COL OW PURPLE (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Current NDC, 4 package rows20240926_ea0db59f-f9c0-49a8-9717-69cdf071f6e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNea0db59f-f9c0-49a8-9717-69cdf071f6e14
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDea0db59f-f9c0-49a8-9717-69cdf071f6e14
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYea0db59f-f9c0-49a8-9717-69cdf071f6e14
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYea0db59f-f9c0-49a8-9717-69cdf071f6e14
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYea0db59f-f9c0-49a8-9717-69cdf071f6e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-419-58350000419581 TUBE in 1 CARTON (35000-419-58) / 71 g in 1 TUBE1 tube2024-04-01NoNoCurrent
35000-419-71350000419711 TUBE in 1 CARTON (35000-419-71) / 120 g in 1 TUBE1 tube2023-10-01NoNoCurrent