FDA.reportPublic FDA data

Crest Pro Health

Product NDC
69423-761
11-digit product format
694230761
Labeler code
69423
Product ID
69423-761_47e2fdce-a5fa-4ee6-e063-6394a90a2526
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
2023-02-15
Substance
STANNOUS FLUORIDE
Active strength
1.5 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 Pro Health
Brand name suffix
Enamel Repair and Gum Intensive Clean
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
f4c2118d-1216-d0d0-e053-2995a90a7088Available 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
69423-761-06Crest Pro HealthEnamel Repair and Gum Intensive Clean1 in 1 CARTONPASTE, DENTIFRICE18
69423-761-06Crest Pro HealthEnamel Repair and Gum Intensive Clean6 in 1 CELLO PACKPASTE, DENTIFRICE68
69423-761-37Crest Pro HealthEnamel Repair and Gum Intensive Clean1 in 1 CARTONPASTE, DENTIFRICE18
69423-761-37Crest Pro HealthEnamel Repair and Gum Intensive Clean104 g in 1 TUBEPASTE, DENTIFRICE1048
69423-761-41Crest Pro HealthEnamel Repair and Gum Intensive Clean1 in 1 CARTONPASTE, DENTIFRICE18
69423-761-41Crest Pro HealthEnamel Repair and Gum Intensive Clean116 g in 1 TUBEPASTE, DENTIFRICE1168
69423-761-48Crest Pro HealthEnamel Repair and Gum Intensive Clean1 in 1 CARTONPASTE, DENTIFRICE18
69423-761-48Crest Pro HealthEnamel Repair and Gum Intensive Clean136 g in 1 TUBEPASTE, DENTIFRICE1368

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-761CREST PRO HEALTH ENAMEL REPAIR AND GUM INTENSIVE CLEAN (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, 8 package rows20250321_f4c2118d-1216-d0d0-e053-2995a90a7088.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 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
TOMS OF MAINE WHOLE CARE WINTERMINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.d5e1396e-0253-4ec0-a9ff-b61bda70de352026-08-10WarningsExact identifier
application number: M021
TOMS OF MAINE WICKED COOL MILD MINTSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.de92408c-d401-47c3-94ee-fb6c080926512026-08-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf4c2118d-1216-d0d0-e053-2995a90a70888
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf4c2118d-1216-d0d0-e053-2995a90a70888
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf4c2118d-1216-d0d0-e053-2995a90a70888
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf4c2118d-1216-d0d0-e053-2995a90a70888
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf4c2118d-1216-d0d0-e053-2995a90a70888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-761-06694230761066 CARTON in 1 CELLO PACK (69423-761-06) / 1 TUBE in 1 CARTON / 73 g in 1 TUBE6 carton2025-01-07NoNoCurrent
69423-761-37694230761371 TUBE in 1 CARTON (69423-761-37) / 104 g in 1 TUBE1 tube2023-02-15NoNoCurrent
69423-761-41694230761411 TUBE in 1 CARTON (69423-761-41) / 116 g in 1 TUBE1 tube2023-02-15NoNoCurrent
69423-761-48694230761481 TUBE in 1 CARTON (69423-761-48) / 136 g in 1 TUBE1 tube2023-02-15NoNoCurrent