FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-611
11-digit product format
841260611
Labeler code
84126
Product ID
84126-611_561a9408-3973-ad00-e063-6394a90ac830
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-07
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
2 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
Deep Stain Remover Ultra White
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE2 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
2f24a9eb-7a89-30e1-e063-6394a90a032bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-611-02Crest 3D WhiteDeep Stain Remover Ultra White59 g in 1 TUBEPASTE, DENTIFRICE596
84126-611-02Crest 3D WhiteDeep Stain Remover Ultra White2 in 1 CARTONPASTE, DENTIFRICE26
84126-611-03Crest 3D WhiteDeep Stain Remover Ultra White87 g in 1 TUBEPASTE, DENTIFRICE876
84126-611-03Crest 3D WhiteDeep Stain Remover Ultra White2 in 1 CARTONPASTE, DENTIFRICE26
84126-611-04Crest 3D WhiteDeep Stain Remover Ultra White4 in 1 CARTONPASTE, DENTIFRICE46
84126-611-04Crest 3D WhiteDeep Stain Remover Ultra White59 g in 1 TUBEPASTE, DENTIFRICE596
84126-611-21Crest 3D WhiteDeep Stain Remover Ultra White59 g in 1 TUBEPASTE, DENTIFRICE596
84126-611-21Crest 3D WhiteDeep Stain Remover Ultra White1 in 1 CARTONPASTE, DENTIFRICE16
84126-611-31Crest 3D WhiteDeep Stain Remover Ultra White87 g in 1 TUBEPASTE, DENTIFRICE876
84126-611-31Crest 3D WhiteDeep Stain Remover Ultra White1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-611CREST 3D WHITE DEEP STAIN REMOVER ULTRA WHITE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 10 package rows20250302_2f24a9eb-7a89-30e1-e063-6394a90a032b.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
1038995sodium monofluorophosphate 1.14 % ToothpastePSN2f24a9eb-7a89-30e1-e063-6394a90a032b6
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD2f24a9eb-7a89-30e1-e063-6394a90a032b6
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY2f24a9eb-7a89-30e1-e063-6394a90a032b6
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY2f24a9eb-7a89-30e1-e063-6394a90a032b6
1038995sodium monofluorophosphate 1.14 % ToothpasteSY2f24a9eb-7a89-30e1-e063-6394a90a032b6
1038995sodium monofluorophosphate 1.14 % ToothpastePSN3c57d487-a3c7-b238-e063-6294a90aed812
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD3c57d487-a3c7-b238-e063-6294a90aed812
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY3c57d487-a3c7-b238-e063-6294a90aed812
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY3c57d487-a3c7-b238-e063-6294a90aed812
1038995sodium monofluorophosphate 1.14 % ToothpasteSY3c57d487-a3c7-b238-e063-6294a90aed812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-611-02841260611022 TUBE in 1 CARTON (84126-611-02) / 59 g in 1 TUBE2 tube2026-01-06NoNoCurrent
84126-611-03841260611032 TUBE in 1 CARTON (84126-611-03) / 87 g in 1 TUBE2 tube2025-05-01NoNoCurrent
84126-611-04841260611044 TUBE in 1 CARTON (84126-611-04) / 59 g in 1 TUBE4 tube2023-01-07NoNoCurrent
84126-611-21841260611211 TUBE in 1 CARTON (84126-611-21) / 59 g in 1 TUBE1 tube2023-01-07NoNoCurrent
84126-611-31841260611311 TUBE in 1 CARTON (84126-611-31) / 87 g in 1 TUBE1 tube2023-01-07NoNoCurrent
84126-611-85841260611851 TUBE in 1 CARTON (84126-611-85) / 24 g in 1 TUBE1 tube2026-07-01NoNoCurrent