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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company3bba340e-2a62-3b04-41b5-0ed9c13adb132026-04-22WarningsExact identifier
application number: M021
EverSmile SquirtSODIUM FLUORIDE 0.05%Everbrands, Inc.bc0ef174-2909-469a-b629-0eab4412bdfc2026-04-20WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmart41d6cc7a-0b87-e474-e063-6294a90ae9952026-04-20WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf2026-04-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEH E B8d40f693-083c-4eb6-9da1-42675d757e0e2026-04-16Warnings, Adverse reactionsExact identifier
application number: M021
Eversmile OrthoFoam Anticavity0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.9c12e792-94c8-4e29-9a54-e7e70aadade62026-04-16WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.6753b426-6d49-4438-a52f-c28e60a0e9d82026-04-16WarningsExact identifier
application number: M021
Osstem G Gum Health Care ToothSODIUM FLUORIDEOsstem Pharma Co., Ltd4f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Enamel StrengthSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4f6b8851-c778-8abd-e063-6294a90aef4f2026-04-14Exact identifier
application number: M021
Crest 3D White Stain Eraser Luxe MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6beb3b-2521-bfb7-e063-6394a90ad9ea2026-04-14Exact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d132026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6d11b2-5aa2-ab34-e063-6294a90ac0bc2026-04-14WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEPublix Super Markets, Inc.cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb2026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.f0e84078-499f-4a5a-bcd2-23f57805de862026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
Crest Pro-Health Advanced Multi-ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1cfc5b61-c8e5-943d-e063-6394a90a890b2026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Multi-Protection plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6f6299-f95f-2f0e-e063-6294a90a16412026-04-14WarningsExact identifier
application number: M021
Crest 3D White Strength Whitening Enamel ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f7125aa-3aa2-ca64-e063-6394a90a4cf32026-04-14WarningsExact identifier
application number: M021
Eversmile TheraFoam0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.57da2479-923a-45ec-8149-57b469b116372026-04-13WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company4f1d62ae-653e-3046-e063-6294a90abbf82026-04-10WarningsExact 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