FDA.reportPublic FDA data

Colgate Optic White Pro Series Stain Prevention

Product NDC
35000-747
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35000-747DDiscontinued by firm2026-10-05
excluded packagepackage35000-74735000-747-16DDiscontinued by firm2026-10-05
excluded packagepackage35000-74735000-747-21DDiscontinued by firm2026-10-05
excluded packagepackage35000-74735000-747-30DDiscontinued by firm2026-10-05
excluded packagepackage35000-74735000-747-32DDiscontinued 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 · 11 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0535000-747-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-747-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-747-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-747-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-747-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-747-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-747-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-747-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-747-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-747-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-747-160efc9e666f02…f202fb6c5f17…

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
35000-747-16350000747161 TUBE in 1 CARTON (35000-747-16) > 6 g in 1 TUBE1 tube2021-11-250000-00-00NoNoCurrent
35000-747-21350000747211 TUBE in 1 CARTON (35000-747-21) > 59 g in 1 TUBE1 tube2021-11-250000-00-00NoNoCurrent
35000-747-30350000747301 TUBE in 1 CARTON (35000-747-30) > 85 g in 1 TUBE1 tube2021-11-250000-00-00NoNoCurrent
35000-747-32350000747321 TUBE in 1 CARTON (35000-747-32) > 93 g in 1 TUBE1 tube2021-11-250000-00-00NoNoCurrent