FDA.reportPublic FDA data

COLGATE

Product NDC
35000-907
11-digit product format
350000907
Labeler code
35000
Product ID
35000-907_8aed9b0a-e131-400e-b3c4-764c27251ca8
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-26
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35000-907DDiscontinued by firm2026-10-15
excluded packagepackage35000-90735000-907-81DDiscontinued by firm2026-10-15

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
35000-907-81COLGATE2IN1 WHITENING STAIN LIFTERS130 g in 1 BOTTLEGEL, DENTIFRICE1302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-907COLGATE 2IN1 WHITENING STAIN LIFTERS (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]2Legacy NDC, 1 package rows20241020_26f1f873-06b2-45ef-a4b9-32f997642bc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN26f1f873-06b2-45ef-a4b9-32f997642bc72
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD26f1f873-06b2-45ef-a4b9-32f997642bc72
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY26f1f873-06b2-45ef-a4b9-32f997642bc72
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY26f1f873-06b2-45ef-a4b9-32f997642bc72
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY26f1f873-06b2-45ef-a4b9-32f997642bc72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-907-8135000090781130 g in 1 BOTTLE (35000-907-81) 130 g2011-07-260000-00-00NoNoCurrent