FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-628
11-digit product format
841260628
Labeler code
84126
Product ID
84126-628_4f08260b-c544-87ed-e063-6394a90a3639
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
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
Advanced Arctic Fresh with Stain-Blasting Foam
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
4ef4146d-6281-fe66-e063-6394a90a32c3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-628-04Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam2 in 1 CELLO PACKPASTE, DENTIFRICE23
84126-628-04Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-05Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-05Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam2 in 1 CELLO PACKPASTE, DENTIFRICE23
84126-628-06Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-06Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam3 in 1 CELLO PACKPASTE, DENTIFRICE33
84126-628-24Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam68 g in 1 TUBEPASTE, DENTIFRICE683
84126-628-24Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-33Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-33Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam93 g in 1 TUBEPASTE, DENTIFRICE933
84126-628-49Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam139 g in 1 TUBEPASTE, DENTIFRICE1393
84126-628-49Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13

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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toms of Maine Whiten Plus Deep Clean PeppermintSODIUM FLUORIDETom's of Maine4c535776-3f80-4eeb-bb63-2d734c3c3a6b2026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDETopco Associates LLCade7dcb2-b4e2-4cef-b9a7-469867ead68a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDETopco Associates LLC84b30711-a7e5-4189-895a-a7989f05591c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchanges581d5cdb-018a-42ad-899d-5331f00633762026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-628-04841260628042 CARTON in 1 CELLO PACK (84126-628-04) / 1 TUBE in 1 CARTON / 68 g in 1 TUBE2 carton2026-01-01NoNoCurrent
84126-628-05841260628052 CARTON in 1 CELLO PACK (84126-628-05) / 1 TUBE in 1 CARTON / 93 g in 1 TUBE2 carton2026-01-01NoNoCurrent
84126-628-06841260628063 CARTON in 1 CELLO PACK (84126-628-06) / 1 TUBE in 1 CARTON / 93 g in 1 TUBE3 carton2026-01-01NoNoCurrent
84126-628-24841260628241 TUBE in 1 CARTON (84126-628-24) / 68 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-628-33841260628331 TUBE in 1 CARTON (84126-628-33) / 93 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-628-49841260628491 TUBE in 1 CARTON (84126-628-49) / 139 g in 1 TUBE1 tube2026-01-01NoNoCurrent