Colgate Optic White Pro Series Stain Prevention

Product NDC
35000-747
11-digit product format
350000747
Labeler code
35000
Product ID
35000-747_df2fcc38-8861-47b5-ae6d-d1893f4a09a8
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-23
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 firm2026-08-17
excluded packagepackage35000-74735000-747-16DDiscontinued by firm2026-08-17
excluded packagepackage35000-74735000-747-21DDiscontinued by firm2026-08-17
excluded packagepackage35000-74735000-747-30DDiscontinued by firm2026-08-17
excluded packagepackage35000-74735000-747-32DDiscontinued by firm2026-08-17

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…

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]4Current NDC, Legacy NDC, 8 package rows20241127_e18060c0-7e03-444c-a5ac-b8ba25ce14ea.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 52 · 1,037 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Colgate Max Fresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
COLGATE 2IN1 WHITENING STAIN LIFTERSSODIUM FLUORIDEColgate-Palmolive Company26f1f873-06b2-45ef-a4b9-32f997642bc72026-08-17WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HI WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-17WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
application number: M021

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