FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-644
11-digit product format
841260644
Labeler code
84126
Product ID
84126-644_4f6b119d-9a7f-c7fa-e063-6394a90a7e17
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-06
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
2 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
Deep Stain Remover Enamel Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE2 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038995Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f6b8851-c778-8abd-e063-6294a90aef4fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-644-21Crest 3D WhiteDeep Stain Remover Enamel Strength1 in 1 CARTONPASTE, DENTIFRICE11
84126-644-21Crest 3D WhiteDeep Stain Remover Enamel Strength59 g in 1 TUBEPASTE, DENTIFRICE591
84126-644-31Crest 3D WhiteDeep Stain Remover Enamel Strength1 in 1 CARTONPASTE, DENTIFRICE11
84126-644-31Crest 3D WhiteDeep Stain Remover Enamel Strength87 g in 1 TUBEPASTE, DENTIFRICE871

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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSN4f6b8851-c778-8abd-e063-6294a90aef4f1
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD4f6b8851-c778-8abd-e063-6294a90aef4f1
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY4f6b8851-c778-8abd-e063-6294a90aef4f1
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY4f6b8851-c778-8abd-e063-6294a90aef4f1
1038995sodium monofluorophosphate 1.14 % ToothpasteSY4f6b8851-c778-8abd-e063-6294a90aef4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-644-21841260644211 TUBE in 1 CARTON (84126-644-21) / 59 g in 1 TUBE1 tube2026-01-06NoNoCurrent
84126-644-31841260644311 TUBE in 1 CARTON (84126-644-31) / 87 g in 1 TUBE1 tube2026-01-06NoNoCurrent