FDA.reportPublic FDA data

Crest 3D White

Product NDC
69423-768
11-digit product format
694230768
Labeler code
69423
Product ID
69423-768_47e5cb38-b55d-9cfb-e063-6394a90a8fda
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
2020-10-11
Substance
SODIUM FLUORIDE
Active strength
1.6 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-76869423-768-39DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-76869423-768-39DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-76869423-768-39DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 Glamorous White
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.6 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
f5b18988-68c7-40f9-e053-2995a90a22bcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-768-03Crest 3D WhiteAdvanced Glamorous White3 in 1 CELLO PACKPASTE, DENTIFRICE312
69423-768-03Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112
69423-768-23Crest 3D WhiteAdvanced Glamorous White2 in 1 CARTONPASTE, DENTIFRICE212
69423-768-23Crest 3D WhiteAdvanced Glamorous White93 g in 1 TUBEPASTE, DENTIFRICE9312
69423-768-38Crest 3D WhiteAdvanced Glamorous White107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-768-38Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112
69423-768-39Crest 3D WhiteAdvanced Glamorous White107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-768-39Crest 3D WhiteAdvanced Glamorous White3 in 1 CARTONPASTE, DENTIFRICE312
69423-768-66Crest 3D WhiteAdvanced Glamorous White187 g in 1 TUBEPASTE, DENTIFRICE18712
69423-768-66Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112
69423-768-77Crest 3D WhiteAdvanced Glamorous White2 in 1 CARTONPASTE, DENTIFRICE212
69423-768-77Crest 3D WhiteAdvanced Glamorous White107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-768-93Crest 3D WhiteAdvanced Glamorous White93 g in 1 TUBEPASTE, DENTIFRICE9312
69423-768-93Crest 3D WhiteAdvanced Glamorous White1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-768CREST 3D WHITE ADVANCED GLAMOROUS WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, 14 package rows20250115_f5b18988-68c7-40f9-e053-2995a90a22bc.zip

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
891775sodium fluoride 0.243 % ToothpastePSNf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYf5b18988-68c7-40f9-e053-2995a90a22bc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-768-03694230768033 CARTON in 1 CELLO PACK (69423-768-03) / 1 TUBE in 1 CARTON / 93 g in 1 TUBE3 carton2020-10-11NoNoCurrent
69423-768-23694230768232 TUBE in 1 CARTON (69423-768-23) / 93 g in 1 TUBE2 tube2020-10-11NoNoCurrent
69423-768-38694230768381 TUBE in 1 CARTON (69423-768-38) / 107 g in 1 TUBE1 tube2021-08-01NoNoCurrent
69423-768-3969423076839107 g in 1 TUBE107 gHistorical
69423-768-66694230768661 TUBE in 1 CARTON (69423-768-66) / 187 g in 1 TUBE1 tube2025-04-01NoNoCurrent
69423-768-77694230768772 TUBE in 1 CARTON (69423-768-77) / 107 g in 1 TUBE2 tube2021-08-01NoNoCurrent
69423-768-93694230768931 TUBE in 1 CARTON (69423-768-93) / 93 g in 1 TUBE1 tube2024-01-31NoNoCurrent