FDA.reportPublic FDA data

Colgate Essentials

Product NDC
35000-974
Requested package NDC
35000-974-46
11-digit product format
350000974
Labeler code
35000
Product ID
35000-974_6d97615f-1157-47de-bb51-43603cffbb8e
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-04-09
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-97435000-974-46DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
35000-974-46Colgate Essentials1 in 1 CARTONPASTE, DENTIFRICE14
35000-974-46Colgate Essentials130 g in 1 TUBEPASTE, DENTIFRICE1304
35000-974-61Colgate Essentials172 g in 1 TUBEPASTE, DENTIFRICE1724
35000-974-61Colgate Essentials1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-974COLGATE ESSENTIALS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Legacy NDC, 4 package rows20241128_30e98e1a-ac3f-40dc-9fd2-d2fba1314527.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN30e98e1a-ac3f-40dc-9fd2-d2fba13145274
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD30e98e1a-ac3f-40dc-9fd2-d2fba13145274
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY30e98e1a-ac3f-40dc-9fd2-d2fba13145274
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY30e98e1a-ac3f-40dc-9fd2-d2fba13145274
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY30e98e1a-ac3f-40dc-9fd2-d2fba13145274
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY30e98e1a-ac3f-40dc-9fd2-d2fba13145274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-974-46350000974461 TUBE in 1 CARTON (35000-974-46) > 130 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent