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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact 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