Colgate Kids Maximum Cavity Protection Batman

Product NDC
35000-191
Requested package NDC
35000-191-44
11-digit product format
350000191
Labeler code
35000
Product ID
35000-191_94c22077-bc62-491d-b7d1-45ec1817a34e
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-02-22
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage35000-19135000-191-44DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-191COLGATE KIDS MAXIMUM CAVITY PROTECTION BATMAN (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE]3Legacy NDC20240228_fdbaa1e5-92da-e7cb-fe77-41e53d17f3e4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-191-4435000019144124 g in 1 TUBE (35000-191-44) 124 g2021-02-220000-00-00NoNoCurrent