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 17 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960e0e3e-10e8-7426-e053-2a95a90a5b022026-02-12WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e2026-02-12WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company126c6f39-0ef7-40ee-b3ba-e56a76739c572026-02-12WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.b2f7490c-e2af-49df-b054-70fb4815f7292026-02-11Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INC287887df-64de-4b5d-80e2-146c77c0fa8b2026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES White Care AO ProSODIUM FLUORIDEPERIOSCIENCES LLC092bdfa3-6267-439e-9320-e51b4805d1a12026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES HYDRATING AO ProSODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLC5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d32026-02-09WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERetail Business Services, LLC77c066cf-f064-45d3-9732-4433165ba9ef2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDERetail Business Services, LLCd1c878a9-2151-4986-be09-cbab658cdd312026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDERetail Business Services, LLC542e067a-c134-44c9-b962-f2a2b667b76f2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERetail Business Services, LLC3954edfd-f7f1-4218-9ee2-23f5b3661b4e2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Kids Anticavity Oral Rinse BubblegumANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.2770424d-7416-66d4-e063-6394a90ad4b12026-02-06WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity Whitening Plus ScopeSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company463b7820-a5ce-f8b5-e063-6394a90aa0182026-02-05WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.14494238-872b-49e2-8bf7-df3844a0a6c82026-02-05Warnings, Adverse reactionsExact identifier
application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150SODIUM MONOFLUOROPHOSPHATELAMOIYAN CORPORATION14c14694-6149-40a8-aff2-660d39f7e0c12026-02-05WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEHARRIS TEETERf759e9e4-6de2-4b80-903b-e67c06e362952026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEHARRIS TEETER571f7628-fd59-462f-96dd-67aeaa98cff12026-02-04Warnings, Adverse reactionsExact 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