FDA.reportPublic FDA data

Crest 3D White

Product NDC
69423-767
11-digit product format
694230767
Labeler code
69423
Product ID
69423-767_4ee0534f-21b4-92f4-e063-6394a90a98a8
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
2023-02-17
Substance
SODIUM FLUORIDE
Active strength
1.5 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 packagepackage69423-76769423-767-29DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Charcoal
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
f4eb8111-53da-17ae-e053-2a95a90a1127Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-767-03Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-03Crest 3D WhiteAdvanced Charcoal93 g in 1 TUBEPASTE, DENTIFRICE9312
69423-767-24Crest 3D WhiteAdvanced Charcoal68 g in 1 TUBEPASTE, DENTIFRICE6812
69423-767-24Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-27Crest 3D WhiteAdvanced Charcoal76 g in 1 TUBEPASTE, DENTIFRICE7612
69423-767-27Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-28Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-28Crest 3D WhiteAdvanced Charcoal2 in 1 CELLO PACKPASTE, DENTIFRICE212
69423-767-29Crest 3D WhiteAdvanced Charcoal3 in 1 CELLO PACKPASTE, DENTIFRICE312
69423-767-29Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-33Crest 3D WhiteAdvanced Charcoal2 in 1 CARTONPASTE, DENTIFRICE212
69423-767-33Crest 3D WhiteAdvanced Charcoal93 g in 1 TUBEPASTE, DENTIFRICE9312
69423-767-38Crest 3D WhiteAdvanced Charcoal107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-767-38Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-39Crest 3D WhiteAdvanced Charcoal3 in 1 CELLO PACKPASTE, DENTIFRICE312
69423-767-39Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-66Crest 3D WhiteAdvanced Charcoal1 in 1 CARTONPASTE, DENTIFRICE112
69423-767-66Crest 3D WhiteAdvanced Charcoal187 g in 1 TUBEPASTE, DENTIFRICE18712
69423-767-76Crest 3D WhiteAdvanced Charcoal107 g in 1 TUBEPASTE, DENTIFRICE10712
69423-767-76Crest 3D WhiteAdvanced Charcoal2 in 1 CARTONPASTE, DENTIFRICE212
69423-767-93Crest 3D WhiteAdvanced Charcoal3 in 1 CARTONPASTE, DENTIFRICE312
69423-767-93Crest 3D WhiteAdvanced Charcoal93 g in 1 TUBEPASTE, DENTIFRICE9312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-767CREST 3D WHITE ADVANCED CHARCOAL (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, 22 package rows20250115_f4eb8111-53da-17ae-e053-2a95a90a1127.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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINTSODIUM FLUORIDETom's of Maine, Inc.b9e6e455-8444-4805-89f1-ee9142f98e362026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.7db8e49d-1073-4a81-a3a4-f3a19ebce9212026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINTSODIUM FLUORIDETom's of Maine, Inc.1fe50b49-bc62-4137-866c-e87bb878a96d2026-08-10WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNf4eb8111-53da-17ae-e053-2a95a90a112712
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDf4eb8111-53da-17ae-e053-2a95a90a112712
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYf4eb8111-53da-17ae-e053-2a95a90a112712
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYf4eb8111-53da-17ae-e053-2a95a90a112712
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYf4eb8111-53da-17ae-e053-2a95a90a112712
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYf4eb8111-53da-17ae-e053-2a95a90a112712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-767-03694230767031 TUBE in 1 CARTON (69423-767-03) / 93 g in 1 TUBE1 tube2023-02-17NoNoCurrent
69423-767-24694230767241 TUBE in 1 CARTON (69423-767-24) / 68 g in 1 TUBE1 tube2023-02-17NoNoCurrent
69423-767-27694230767271 TUBE in 1 CARTON (69423-767-27) / 76 g in 1 TUBE1 tube2023-02-17NoNoCurrent
69423-767-28694230767282 CARTON in 1 CELLO PACK (69423-767-28) / 1 TUBE in 1 CARTON / 76 g in 1 TUBE2 carton2023-02-17NoNoCurrent
69423-767-29694230767293 in 1 CELLO PACKHistorical
69423-767-33694230767332 TUBE in 1 CARTON (69423-767-33) / 93 g in 1 TUBE2 tube2023-04-01NoNoCurrent
69423-767-38694230767381 TUBE in 1 CARTON (69423-767-38) / 107 g in 1 TUBE1 tube2023-02-17NoNoCurrent
69423-767-39694230767393 CARTON in 1 CELLO PACK (69423-767-39) / 1 TUBE in 1 CARTON / 107 g in 1 TUBE3 carton2023-02-17NoNoCurrent
69423-767-66694230767661 TUBE in 1 CARTON (69423-767-66) / 187 g in 1 TUBE1 tube2025-04-01NoNoCurrent
69423-767-76694230767762 TUBE in 1 CARTON (69423-767-76) / 107 g in 1 TUBE2 tube2023-02-17NoNoCurrent
69423-767-93694230767933 TUBE in 1 CARTON (69423-767-93) / 93 g in 1 TUBE3 tube2026-01-01NoNoCurrent