FDA.reportPublic FDA data

Crest 3D White

Product NDC
69423-768
Requested package NDC
69423-768-77
11-digit product format
694230768
Labeler code
69423
Product ID
69423-768_47e5cb38-b55d-9cfb-e063-6394a90a8fda
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-11
Substance
SODIUM FLUORIDE
Active strength
1.6 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
Crest 3D White
Brand name suffix
Advanced Glamorous White
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.6 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5b18988-68c7-40f9-e053-2995a90a22bcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-768-03Crest 3D WhiteAdvanced Glamorous White3 in 1 CELLO PACKPASTE, DENTIFRICE312
69423-768-03Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112
69423-768-23Crest 3D WhiteAdvanced Glamorous White2 in 1 CARTONPASTE, DENTIFRICE212
69423-768-23Crest 3D WhiteAdvanced Glamorous White93 g in 1 TUBEPASTE, DENTIFRICE9312
69423-768-38Crest 3D WhiteAdvanced Glamorous White107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-768-38Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112
69423-768-39Crest 3D WhiteAdvanced Glamorous White107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-768-39Crest 3D WhiteAdvanced Glamorous White3 in 1 CARTONPASTE, DENTIFRICE312
69423-768-66Crest 3D WhiteAdvanced Glamorous White187 g in 1 TUBEPASTE, DENTIFRICE18712
69423-768-66Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112
69423-768-77Crest 3D WhiteAdvanced Glamorous White2 in 1 CARTONPASTE, DENTIFRICE212
69423-768-77Crest 3D WhiteAdvanced Glamorous White107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-768-93Crest 3D WhiteAdvanced Glamorous White93 g in 1 TUBEPASTE, DENTIFRICE9312
69423-768-93Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-768CREST 3D WHITE ADVANCED GLAMOROUS WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, 14 package rows20250115_f5b18988-68c7-40f9-e053-2995a90a22bc.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
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
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-768-77694230768772 TUBE in 1 CARTON (69423-768-77) / 107 g in 1 TUBE2 tube2021-08-01NoNoCurrent