FDA.reportPublic FDA data

Colgate Essentials

Product NDC
65954-786
11-digit product format
659540786
Labeler code
65954
Product ID
65954-786_f2ae22cc-7f47-4172-8e03-2a1de53c63ed
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-09
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
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 Essentials
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

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
65954-786-46Colgate Essentials1 in 1 CARTONPASTE, DENTIFRICE17
65954-786-46Colgate Essentials130 g in 1 TUBEPASTE, DENTIFRICE1307
65954-786-61Colgate Essentials1 in 1 CARTONPASTE, DENTIFRICE17
65954-786-61Colgate Essentials172 g in 1 TUBEPASTE, DENTIFRICE1727

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-786COLGATE ESSENTIALS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]7Current NDC, Legacy NDC, 4 package rows20241127_01c205e0-8419-47a4-ba9e-403251966ed5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN01c205e0-8419-47a4-ba9e-403251966ed57
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD01c205e0-8419-47a4-ba9e-403251966ed57
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY01c205e0-8419-47a4-ba9e-403251966ed57
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY01c205e0-8419-47a4-ba9e-403251966ed57
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY01c205e0-8419-47a4-ba9e-403251966ed57
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY01c205e0-8419-47a4-ba9e-403251966ed57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-786-46659540786461 TUBE in 1 CARTON (65954-786-46) / 130 g in 1 TUBE1 tube2018-10-12NoNoCurrent
65954-786-61659540786611 in 1 CARTONHistorical