FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-653
11-digit product format
841260653
Labeler code
84126
Product ID
84126-653_5c3d01ff-ef63-4cc3-e063-6294a90a94c2
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
2026-04-06
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
Ultra Whitening with Stain-Blasting Foam Vivid Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-653-05Crest 3D WhiteUltra Whitening with Stain-Blasting Foam Vivid Mint5 in 1 CELLO PACKPASTE, DENTIFRICE51
84126-653-05Crest 3D WhiteUltra Whitening with Stain-Blasting Foam Vivid Mint1 in 1 CARTONPASTE, DENTIFRICE11
84126-653-52Crest 3D WhiteUltra Whitening with Stain-Blasting Foam Vivid Mint1 in 1 CARTONPASTE, DENTIFRICE11
84126-653-52Crest 3D WhiteUltra Whitening with Stain-Blasting Foam Vivid Mint147 g in 1 TUBEPASTE, DENTIFRICE1471

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 14 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEOld East Main Co.64f3d92d-f58c-4bc2-8819-f91492221ddb2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.c7b9e9cd-3cf7-4657-83c9-e221e1c359772026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
Instant WhiteningINSTANT WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2807ece8-a1a5-b626-e063-6394a90aac622026-03-02WarningsExact identifier
application number: M021
Coffe Tea Stain Remover ToothCOFFE TEA STAIN REMOVER TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2845d7af-7a0b-9bc8-e063-6294a90ac8b32026-03-02WarningsExact identifier
application number: M021
Professional whitening toothPROFESSIONAL WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291eba71-14da-fac3-e063-6294a90aa3cc2026-03-02WarningsExact identifier
application number: M021
purple toothPURPLE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291f0312-238c-71d5-e063-6294a90a39e12026-03-02WarningsExact identifier
application number: M021
Professional ChoicePROFESSIONAL CHOICE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd28406739-6a8c-1ce8-e063-6394a90a08f82026-03-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.27a98b64-8369-4f3d-b487-d7ce98abc69f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.390dd1b5-2dd1-4b55-b4b3-e441ada612382026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEThe Kroger Co.5459eeee-adf0-4afe-b190-62d4fa1138062026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEThe Kroger Co.932723b8-9875-4f37-8c11-018c94ae0ae12026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.d0c552d8-44ad-4d95-b3fb-17015f44b3342026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEWalmart Inc.3beb65e4-ae8e-4e51-b9ba-181cbec41eff2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.61669087-0af6-4192-b514-afcfe7d8ba982026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEWalmart Inc.1fd2f3ca-066e-282a-e063-6294a90a05a92026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.af5b93e7-5cce-4e01-8df2-54494d8b29102026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.4590ca97-130c-46b2-9ba0-38f4703ef30a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32a92add-c9db-4733-8e35-613825fdf0812026-02-24Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN50868eb9-6dd4-9f41-e063-6394a90a7f531
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD50868eb9-6dd4-9f41-e063-6394a90a7f531
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY50868eb9-6dd4-9f41-e063-6394a90a7f531
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY50868eb9-6dd4-9f41-e063-6394a90a7f531
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY50868eb9-6dd4-9f41-e063-6394a90a7f531
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY50868eb9-6dd4-9f41-e063-6394a90a7f531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-653-04841260653044 CARTON in 1 CARTON (84126-653-04) / 1 TUBE in 1 CARTON / 141 g in 1 TUBE4 carton2026-09-04NoNoCurrent
84126-653-05841260653055 CARTON in 1 CELLO PACK (84126-653-05) / 1 TUBE in 1 CARTON / 147 g in 1 TUBE5 carton2026-04-06NoNoCurrent
84126-653-52841260653521 TUBE in 1 CARTON (84126-653-52) / 147 g in 1 TUBE1 tube2026-04-06NoNoCurrent
84126-653-85841260653851 TUBE in 1 CARTON (84126-653-85) / 24 g in 1 TUBE1 tube2026-04-06NoNoCurrent