FDA.reportPublic FDA data

Colgate Optic White Pro Series Stain Prevention

Product NDC
35000-747
Requested package NDC
35000-747-21
11-digit product format
350000747
Labeler code
35000
Product ID
35000-747_0fba6852-08bf-434e-8e4f-a2ae15c4c6d8
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-11-23
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
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 packagepackage35000-74735000-747-21DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35000-74735000-747-21DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-747-16Colgate Optic White Pro Series Stain Prevention6 g in 1 TUBEPASTE, DENTIFRICE65
35000-747-16Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15
35000-747-21Colgate Optic White Pro Series Stain Prevention59 g in 1 TUBEPASTE, DENTIFRICE595
35000-747-21Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15
35000-747-30Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15
35000-747-30Colgate Optic White Pro Series Stain Prevention85 g in 1 TUBEPASTE, DENTIFRICE855
35000-747-32Colgate Optic White Pro Series Stain Prevention93 g in 1 TUBEPASTE, DENTIFRICE935
35000-747-32Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-747COLGATE OPTIC WHITE PRO SERIES STAIN PREVENTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Legacy NDC, 8 package rows20241127_e18060c0-7e03-444c-a5ac-b8ba25ce14ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNe18060c0-7e03-444c-a5ac-b8ba25ce14ea5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDe18060c0-7e03-444c-a5ac-b8ba25ce14ea5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYe18060c0-7e03-444c-a5ac-b8ba25ce14ea5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYe18060c0-7e03-444c-a5ac-b8ba25ce14ea5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYe18060c0-7e03-444c-a5ac-b8ba25ce14ea5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYe18060c0-7e03-444c-a5ac-b8ba25ce14ea5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-747-21350000747211 TUBE in 1 CARTON (35000-747-21) > 59 g in 1 TUBE1 tube2021-11-250000-00-00NoNoCurrent