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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact identifier
application number: M021
Advance White Tartar Control Breath FresheningSODIUM FLUORIDEChurch & Dwight Co., Inc.aa8be8f5-ba46-4b1b-afaa-58fddf8f87802024-11-20WarningsExact identifier
application number: M021
Enamel DefenseSODIUM FLUORIDEChurch & Dwight Co., Inc.9e8f1ce9-b161-50db-e053-2995a90ad32b2024-11-20WarningsExact identifier
application number: M021
Rembrandt Deeply White Plus PeroxideSODIUM MONOFLUOROPHOSPHATERanir LLCbf7da007-ab9d-4631-bc28-6ca245fd62652024-11-20WarningsExact 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