FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-635
11-digit product format
841260635
Labeler code
84126
Product ID
84126-635_5514741a-cd50-062c-e063-6294a90a7d3a
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
SODIUM FLUORIDE
Active strength
1.5 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
Stain Eraser Daily Stain Prevention Icy Clean Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 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
4f0b1d46-d52c-f409-e063-6394a90a5574Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-635-02Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint107 g in 1 TUBEPASTE, DENTIFRICE1072
84126-635-02Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint2 in 1 CARTONPASTE, DENTIFRICE22
84126-635-03Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint3 in 1 CELLO PACKPASTE, DENTIFRICE32
84126-635-03Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint1 in 1 CARTONPASTE, DENTIFRICE12
84126-635-27Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint1 in 1 CARTONPASTE, DENTIFRICE12
84126-635-27Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint76 g in 1 TUBEPASTE, DENTIFRICE762
84126-635-38Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint1 in 1 CARTONPASTE, DENTIFRICE12
84126-635-38Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint107 g in 1 TUBEPASTE, DENTIFRICE1072

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 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AIM Cavity Protection with WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.a8c742e1-ee61-4593-b8f5-b9e586d39dfc2026-07-01WarningsExact identifier
application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINTSODIUM FLUORIDETom's of Maine6f825520-0f8a-4b4c-bbb6-987f64ab87692026-07-01WarningsExact identifier
application number: M021
Colgate Deep Clean FluorideSODIUM FLUORIDEColgate-Palmolive Company47e8e943-f4d5-40bc-8f79-ec9ea06125de2026-07-01WarningsExact identifier
application number: M021
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
ndc (product): 84126-635
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-635-02841260635022 TUBE in 1 CARTON (84126-635-02) / 107 g in 1 TUBE2 tube2026-01-01NoNoCurrent
84126-635-03841260635033 CARTON in 1 CELLO PACK (84126-635-03) / 1 TUBE in 1 CARTON / 107 g in 1 TUBE3 carton2026-01-01NoNoCurrent
84126-635-27841260635271 TUBE in 1 CARTON (84126-635-27) / 76 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-635-38841260635381 TUBE in 1 CARTON (84126-635-38) / 107 g in 1 TUBE1 tube2026-01-01NoNoCurrent