FDA.reportPublic FDA data

Colgate Optic White Renewal High Impact White

Product NDC
35000-982
Requested package NDC
35000-982-62
11-digit product format
350000982
Labeler code
35000
Product ID
35000-982_5f8d57ef-2ba3-45a4-a783-e65dff284cc9
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
2019-11-04
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-98235000-982-62DDiscontinued by firm2026-08-03

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 · 1,024 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
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Optic White Renewal High Impact White
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b90a131-7933-4501-a174-e35aa95b56c3Available on FDA.report

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]7Current NDC, Legacy 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
35000-982-62350000982622 TUBE in 1 CARTON (35000-982-62) > 85 g in 1 TUBE2 tube2019-11-040000-00-00NoNoCurrent