FDA.reportPublic FDA data

Colgate Optic White Platinum Stain-Less

Product NDC
35000-973
Requested package NDC
35000-973-32
11-digit product format
350000973
Labeler code
35000
Product ID
35000-973_e5975a5c-d478-4796-8f90-6c216dc31f2c
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
2017-11-14
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 packagepackage35000-97335000-973-32DDiscontinued 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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-973-32Colgate Optic White Platinum Stain-Less1 in 1 CARTONPASTE, DENTIFRICE13
35000-973-32Colgate Optic White Platinum Stain-Less90 g in 1 TUBEPASTE, DENTIFRICE903
35000-973-63Colgate Optic White Platinum Stain-Less85 g in 1 TUBEPASTE, DENTIFRICE853
35000-973-63Colgate Optic White Platinum Stain-Less1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-973COLGATE OPTIC WHITE PLATINUM STAIN-LESS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Legacy NDC, 4 package rows20241127_623f0265-4eb6-45a7-916c-ace086696105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN623f0265-4eb6-45a7-916c-ace0866961053
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD623f0265-4eb6-45a7-916c-ace0866961053
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY623f0265-4eb6-45a7-916c-ace0866961053
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY623f0265-4eb6-45a7-916c-ace0866961053
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY623f0265-4eb6-45a7-916c-ace0866961053
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY623f0265-4eb6-45a7-916c-ace0866961053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-973-32350000973321 TUBE in 1 CARTON (35000-973-32) > 90 g in 1 TUBE1 tube2021-12-060000-00-00NoNoCurrent