Crest Pro-Health

Product NDC
69423-765
11-digit product format
694230765
Labeler code
69423
Product ID
69423-765_47e317c2-ea4d-8cce-e063-6394a90a9182
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
STANNOUS 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-76569423-765-16DDiscontinued by firm2026-10-05
excluded packagepackage69423-76569423-765-28DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0569423-765-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569423-765-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669423-765-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669423-765-16f5e01cc5f278…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 Pro-Health
Brand name suffix
Sensitive and Gum All Day Protection
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4d775a1-a4f6-cd69-e053-2995a90a5f64Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-765-03Crest Pro-HealthSensitive and Gum All Day Protection136 g in 1 TUBEPASTE, DENTIFRICE1369
69423-765-03Crest Pro-HealthSensitive and Gum All Day Protection3 in 1 CARTONPASTE, DENTIFRICE39
69423-765-16Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-16Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CELLO PACKPASTE, DENTIFRICE19
69423-765-28Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-28Crest Pro-HealthSensitive and Gum All Day Protection79 g in 1 TUBEPASTE, DENTIFRICE799
69423-765-33Crest Pro-HealthSensitive and Gum All Day Protection3 in 1 CELLO PACKPASTE, DENTIFRICE39
69423-765-33Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-37Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-37Crest Pro-HealthSensitive and Gum All Day Protection104 g in 1 TUBEPASTE, DENTIFRICE1049
69423-765-41Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-41Crest Pro-HealthSensitive and Gum All Day Protection116 g in 1 TUBEPASTE, DENTIFRICE1169
69423-765-46Crest Pro-HealthSensitive and Gum All Day Protection130 g in 1 TUBEPASTE, DENTIFRICE1309
69423-765-46Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-48Crest Pro-HealthSensitive and Gum All Day Protection136 g in 1 TUBEPASTE, DENTIFRICE1369
69423-765-48Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-52Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-52Crest Pro-HealthSensitive and Gum All Day Protection147 g in 1 TUBEPASTE, DENTIFRICE1479
69423-765-85Crest Pro-HealthSensitive and Gum All Day Protection1 in 1 CARTONPASTE, DENTIFRICE19
69423-765-85Crest Pro-HealthSensitive and Gum All Day Protection24 g in 1 TUBEPASTE, DENTIFRICE249

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-765CREST PRO-HEALTH SENSITIVE AND GUM ALL DAY PROTECTION (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, 20 package rows20250125_f4d775a1-a4f6-cd69-e053-2995a90a5f64.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 3 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
application number: M021
SprinJene White BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp8c401bea-0148-46a0-bbb3-80c17f9e8e3e2026-08-14WarningsExact identifier
application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-13WarningsExact identifier
application number: M021
COLGATE STRAWBERRY BURSTSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-13WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRYSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.e36ceb7a-9a29-41d8-8d08-a859e515f1f52026-08-13WarningsExact identifier
application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.08d7ed04-67a4-437a-82c5-496f9893c6c72026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.27278b02-c4fd-4092-a632-a14e442f5a952026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICESODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.59a6b9ac-c28b-4ec3-8231-f35054ce0eaf2026-08-10WarningsExact identifier
application number: M021
Toms Kids Watermelon WiggleSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.48eaafb6-99f4-5fd1-10fc-4ea35cbb2c622026-08-10WarningsExact identifier
application number: M021
AutoBrush kids bubblegumSODIUM FLUORIDELander Enterprises, LLC64b60e74-fceb-4de9-a966-73bf8dbd666c2026-08-10WarningsExact identifier
application number: M021
AutoBrush kids strawberrySODIUM FLUORIDELander Enterprises, LLC7e880d50-8aab-4d57-abc1-e900070f9a112026-08-10WarningsExact identifier
application number: M021
AutoBrush kids watermelonSODIUM FLUORIDELander Enterprises, LLC5cb5eb46-705c-4bb7-bef1-e93a598636fd2026-08-10WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC0e043431-9d87-478d-87f5-5aa8b0a932eb2026-08-10WarningsExact identifier
application number: M021
Willo Minty Mist Dye FreeSODIUM FLUORIDEWillo 32, Inc.3ee5b49e-ca9a-ece6-e063-6394a90a3d002026-08-10WarningsExact identifier
application number: M021
Willo Bubble TwistSODIUM FLUORIDEWillo 32 Inc36560d62-e901-1f93-e063-6394a90a28032026-08-10WarningsExact identifier
application number: M021
Willo Berry Splash Dye FreeSODIUM FLUORIDEWillo 32, Inc3ea91af9-2895-e530-e063-6394a90a39e52026-08-10WarningsExact identifier
application number: M021
Fluoride Mouth Rinse AnticavitySODIUM FLUORIDETarget Corporation3daf3cc3-585a-4bb2-9b56-7117d220ed382026-08-10Warnings, Adverse reactionsExact identifier
application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGOSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.19de1e71-ab94-415f-b66d-e5748dea83172026-08-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf4d775a1-a4f6-cd69-e053-2995a90a5f649
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf4d775a1-a4f6-cd69-e053-2995a90a5f649

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-765-03694230765033 TUBE in 1 CARTON (69423-765-03) / 136 g in 1 TUBE3 tube2023-01-01NoNoCurrent
69423-765-16694230765161 in 1 CARTONHistorical
69423-765-28694230765281 in 1 CARTONHistorical
69423-765-33694230765333 CARTON in 1 CELLO PACK (69423-765-33) / 1 TUBE in 1 CARTON / 104 g in 1 TUBE3 carton2023-01-01NoNoCurrent
69423-765-37694230765371 TUBE in 1 CARTON (69423-765-37) / 104 g in 1 TUBE1 tube2023-02-16NoNoCurrent
69423-765-41694230765411 TUBE in 1 CARTON (69423-765-41) / 116 g in 1 TUBE1 tube2023-02-16NoNoCurrent
69423-765-46694230765461 TUBE in 1 CARTON (69423-765-46) / 130 g in 1 TUBE1 tube2023-02-16NoNoCurrent
69423-765-48694230765481 TUBE in 1 CARTON (69423-765-48) / 136 g in 1 TUBE1 tube2023-02-16NoNoCurrent
69423-765-52694230765521 TUBE in 1 CARTON (69423-765-52) / 147 g in 1 TUBE1 tube2023-02-16NoNoCurrent
69423-765-85694230765851 TUBE in 1 CARTON (69423-765-85) / 24 g in 1 TUBE1 tube2024-04-01NoNoCurrent