FDA.reportPublic FDA data

Crest

Product NDC
69423-787
11-digit product format
694230787
Labeler code
69423
Product ID
69423-787_47e3a0bc-a062-fbba-e063-6294a90af942
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
2022-06-15
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 packagepackage69423-78769423-787-13DDiscontinued 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 · 1 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 packagepackage69423-78769423-787-13DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Brand name suffix
3D White Brilliance Luminous Purple
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
fbfcd837-4d88-5f82-e053-6394a90afbf6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-787-13Crest3D White Brilliance Luminous Purple130 g in 1 TUBEPASTE, DENTIFRICE1308
69423-787-13Crest3D White Brilliance Luminous Purple2 in 1 CARTONPASTE, DENTIFRICE28
69423-787-34Crest3D White Brilliance Luminous Purple130 g in 1 TUBEPASTE, DENTIFRICE1308
69423-787-34Crest3D White Brilliance Luminous Purple3 in 1 CARTONPASTE, DENTIFRICE38
69423-787-35Crest3D White Brilliance Luminous Purple1 in 1 CARTONPASTE, DENTIFRICE18
69423-787-35Crest3D White Brilliance Luminous Purple99 g in 1 TUBEPASTE, DENTIFRICE998
69423-787-46Crest3D White Brilliance Luminous Purple1 in 1 CARTONPASTE, DENTIFRICE18
69423-787-46Crest3D White Brilliance Luminous Purple131 g in 1 TUBEPASTE, DENTIFRICE1318
69423-787-85Crest3D White Brilliance Luminous Purple24 g in 1 TUBEPASTE, DENTIFRICE248
69423-787-85Crest3D White Brilliance Luminous Purple1 in 1 CARTONPASTE, DENTIFRICE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-787CREST 3D WHITE BRILLIANCE LUMINOUS PURPLE (SODIUM FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 10 package rows20250227_fbfcd837-4d88-5f82-e053-6394a90afbf6.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 23 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c82742-fb27-62a2-e053-2a95a90aa7c42026-01-08WarningsExact identifier
application number: M021
Native WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companya5248d35-f488-3457-e053-2995a90a411e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6f9a813-7ed6-895c-e053-2995a90a9ea62026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Dual Blast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb788d16a-8a58-0352-e053-2a95a90a965e2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNfbfcd837-4d88-5f82-e053-6394a90afbf68
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDfbfcd837-4d88-5f82-e053-6394a90afbf68
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYfbfcd837-4d88-5f82-e053-6394a90afbf68
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYfbfcd837-4d88-5f82-e053-6394a90afbf68
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYfbfcd837-4d88-5f82-e053-6394a90afbf68
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYfbfcd837-4d88-5f82-e053-6394a90afbf68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-787-1369423078713130 g in 1 TUBE130 gHistorical
69423-787-34694230787343 TUBE in 1 CARTON (69423-787-34) / 130 g in 1 TUBE3 tube2022-06-15NoNoCurrent
69423-787-35694230787351 TUBE in 1 CARTON (69423-787-35) / 99 g in 1 TUBE1 tube2022-06-15NoNoCurrent
69423-787-46694230787461 TUBE in 1 CARTON (69423-787-46) / 131 g in 1 TUBE1 tube2022-06-15NoNoCurrent
69423-787-85694230787851 TUBE in 1 CARTON (69423-787-85) / 24 g in 1 TUBE1 tube2022-06-15NoNoCurrent