FDA.reportPublic FDA data

Colgate Optic White Advanced Sparkling White

Product NDC
35000-978
11-digit product format
350000978
Labeler code
35000
Product ID
35000-978_ab74961c-dfbd-4213-bb8f-f65cf6be852a
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
2019-10-14
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Sparkling White
Listing expiration
2027-12-31

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
bc56603d-4190-48c1-b16e-3179a650cb39Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-978-14Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-14Colgate Optic White Advanced Sparkling White41 g in 1 TUBEPASTE, DENTIFRICE414
35000-978-16Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-16Colgate Optic White Advanced Sparkling White21.2 g in 1 TUBEPASTE, DENTIFRICE21.24
35000-978-25Colgate Optic White Advanced Sparkling White70.8 g in 1 TUBEPASTE, DENTIFRICE70.84
35000-978-25Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-32Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-32Colgate Optic White Advanced Sparkling White90 g in 1 TUBEPASTE, DENTIFRICE904
35000-978-44Colgate Optic White Advanced Sparkling White127 g in 1 TUBEPASTE, DENTIFRICE1274
35000-978-44Colgate Optic White Advanced Sparkling White2 in 1 CARTONPASTE, DENTIFRICE24
35000-978-71Colgate Optic White Advanced Sparkling White119 g in 1 TUBEPASTE, DENTIFRICE1194
35000-978-71Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-76Colgate Optic White Advanced Sparkling White90 g in 1 TUBEPASTE, DENTIFRICE904
35000-978-76Colgate Optic White Advanced Sparkling White2 in 1 CARTONPASTE, DENTIFRICE24
35000-978-86Colgate Optic White Advanced Sparkling White127 g in 1 TUBEPASTE, DENTIFRICE1274
35000-978-86Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-978COLGATE OPTIC WHITE ADVANCED SPARKLING WHITE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 16 package rows20241017_bc56603d-4190-48c1-b16e-3179a650cb39.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 7 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINTSODIUM FLUORIDEColgate-Palmolive Company9aaa451d-8827-41b7-9661-bc1a7a69cfc32026-06-30WarningsExact identifier
application number: M021
CrestPlus Deep Clean plus Whitening Effervescent MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5579be77-97df-1000-e063-6294a90a47252026-06-30WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTHSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company358842de-3e1d-4f66-8d08-fe8538441b342026-06-29WarningsExact identifier
application number: M021
Anticavity mouth rinse Low-foaming Spearmint718 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited5356d0a8-2db4-ce7f-e063-6394a90aa6d22026-06-26WarningsExact identifier
application number: M021
Colgate Optic White Renewal Brilliant ShineSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company70734d67-fc3e-4515-b6e6-ab2c466578d62026-06-26WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Companyf87d6f04-507a-47ae-8a66-204cf59261c02026-06-26WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513ba92-cadc-2cf3-e063-6294a90ac3e52026-06-25WarningsExact identifier
application number: M021
Crest Plus Active Fresh Scope plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513e40f-b8e8-2d9a-e063-6394a90ab1702026-06-25WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Mint SplashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6c690e-a1bb-4606-e063-6394a90ac4b62026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bbc3d-a1f9-b278-e063-6294a90a62f72026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bd56c-dac8-eb87-e063-6294a90a3cc12026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0b1d46-d52c-f409-e063-6394a90a55742026-06-25Exact identifier
application number: M021
Crest Plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5514e09e-0a7d-93e6-e063-6294a90ae3f02026-06-25WarningsExact identifier
application number: M021
Colgate Sparkling White Mint ZingSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company0c2fe62b-4905-4213-a85b-e073d8eeb7412026-06-24WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Company890c4c29-bba8-4775-a053-10c6292df9302026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55004d9d-eda7-a285-e063-6294a90ad4ca2026-06-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.5500686c-d417-c50a-e063-6294a90ac7fa2026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Dualblast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5500f9ab-b0c4-51d6-e063-6394a90acd382026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5504ec96-aae1-f5f9-e063-6294a90ad8bb2026-06-24WarningsExact identifier
application number: M021
COLGATE SPARKLING WHITE CINNAMINTSODIUM FLUORIDEColgate-Palmolive Companyf2ff18d2-4ef0-454e-a6f1-6f3bf361c7d12026-06-24WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-978-14350000978141 TUBE in 1 CARTON (35000-978-14) / 41 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent
35000-978-16350000978161 TUBE in 1 CARTON (35000-978-16) / 21.2 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent
35000-978-25350000978251 TUBE in 1 CARTON (35000-978-25) / 70.8 g in 1 TUBE1 tube2026-01-01NoNoCurrent
35000-978-32350000978321 TUBE in 1 CARTON (35000-978-32) / 90 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent
35000-978-44350000978442 TUBE in 1 CARTON (35000-978-44) / 127 g in 1 TUBE2 tube2019-10-140000-00-00NoNoCurrent
35000-978-71350000978711 TUBE in 1 CARTON (35000-978-71) / 119 g in 1 TUBE1 tube2019-11-260000-00-00NoNoCurrent
35000-978-76350000978762 TUBE in 1 CARTON (35000-978-76) / 90 g in 1 TUBE2 tube2019-10-140000-00-00NoNoCurrent
35000-978-86350000978861 TUBE in 1 CARTON (35000-978-86) / 127 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent