FDA.reportPublic FDA data

Colgate Optic White Renewal High Impact White

Product NDC
35000-982
Requested package NDC
35000-982-15
11-digit product format
350000982
Labeler code
35000
Product ID
35000-982_47a2f433-4975-4c23-b467-079d84021888
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
2019-11-04
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage35000-98235000-982-15DDiscontinued by firm2026-09-14

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
35000-982-15Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-15Colgate Optic White Renewal High Impact White20 g in 1 TUBEPASTE, DENTIFRICE208
35000-982-41Colgate Optic White Renewal High Impact White116 g in 1 TUBEPASTE, DENTIFRICE1168
35000-982-41Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-43Colgate Optic White Renewal High Impact White121 g in 1 TUBEPASTE, DENTIFRICE1218
35000-982-43Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-62Colgate Optic White Renewal High Impact White85 g in 1 TUBEPASTE, DENTIFRICE858
35000-982-62Colgate Optic White Renewal High Impact White2 in 1 CARTONPASTE, DENTIFRICE28
35000-982-63Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-63Colgate Optic White Renewal High Impact White85 g in 1 TUBEPASTE, DENTIFRICE858

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-982COLGATE OPTIC WHITE RENEWAL HIGH IMPACT WHITE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]7Legacy NDC, 10 package rows20241206_0b90a131-7933-4501-a174-e35aa95b56c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-982-15350000982151 TUBE in 1 CARTON (35000-982-15) > 20 g in 1 TUBE1 tube2019-12-130000-00-00NoNoCurrent