FDA.reportPublic FDA data

COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE

Product NDC
35000-933
11-digit product format
350000933
Labeler code
35000
Product ID
35000-933_ac4c72fc-b386-4c16-afc8-aa344f41f5f6
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
2021-12-01
Marketing end
2027-06-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.5 mg/g
NDC exclude flag
No
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 packagepackage35000-93335000-933-76DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.5 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
1038995Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd805999-86e4-4f6c-9889-fa9a2227d526Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-933-32COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE70.8 g in 1 TUBEPASTE, DENTIFRICE70.81
35000-933-32COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE1 in 1 CARTONPASTE, DENTIFRICE11
35000-933-76COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE90 g in 1 TUBEPASTE, DENTIFRICE901
35000-933-76COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE2 in 1 CARTONPASTE, DENTIFRICE21

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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINTSODIUM FLUORIDETom's of Maine, Inc.b9e6e455-8444-4805-89f1-ee9142f98e362026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.7db8e49d-1073-4a81-a3a4-f3a19ebce9212026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINTSODIUM FLUORIDETom's of Maine, Inc.1fe50b49-bc62-4137-866c-e87bb878a96d2026-08-10WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact 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
ndc (product): 35000-933
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSNcd805999-86e4-4f6c-9889-fa9a2227d5261
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCDcd805999-86e4-4f6c-9889-fa9a2227d5261
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSYcd805999-86e4-4f6c-9889-fa9a2227d5261
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSYcd805999-86e4-4f6c-9889-fa9a2227d5261
1038995sodium monofluorophosphate 1.14 % ToothpasteSYcd805999-86e4-4f6c-9889-fa9a2227d5261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-933-32350000933321 TUBE in 1 CARTON (35000-933-32) / 70.8 g in 1 TUBE1 tube2026-03-012027-06-01NoNoHistorical
35000-933-763500009337690 g in 1 TUBE90 gHistorical
35000-933-90350000933901 TUBE in 1 CARTON (35000-933-90) / 90 g in 1 TUBE1 tube2026-03-012027-06-01NoNoHistorical