FDA.reportPublic FDA data

Crest Pro Health

Product NDC
69423-763
11-digit product format
694230763
Labeler code
69423
Product ID
69423-763_47e30136-9a44-81c5-e063-6394a90a3fbc
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
Gum Detoxify and Restore Pro Deep 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
f4c3ad36-72d8-16e8-e053-2a95a90a8702Available 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
69423-763-13Crest Pro HealthGum Detoxify and Restore Pro Deep Clean3 in 1 CELLO PACKPASTE, DENTIFRICE37
69423-763-13Crest Pro HealthGum Detoxify and Restore Pro Deep Clean1 in 1 CARTONPASTE, DENTIFRICE17
69423-763-25Crest Pro HealthGum Detoxify and Restore Pro Deep Clean1 in 1 CARTONPASTE, DENTIFRICE17
69423-763-25Crest Pro HealthGum Detoxify and Restore Pro Deep Clean70 g in 1 TUBEPASTE, DENTIFRICE707
69423-763-35Crest Pro HealthGum Detoxify and Restore Pro Deep Clean99 g in 1 TUBEPASTE, DENTIFRICE997
69423-763-35Crest Pro HealthGum Detoxify and Restore Pro Deep Clean1 in 1 CARTONPASTE, DENTIFRICE17
69423-763-46Crest Pro HealthGum Detoxify and Restore Pro Deep Clean1 in 1 CARTONPASTE, DENTIFRICE17
69423-763-46Crest Pro HealthGum Detoxify and Restore Pro Deep Clean130 g in 1 TUBEPASTE, DENTIFRICE1307
69423-763-72Crest Pro HealthGum Detoxify and Restore Pro Deep Clean1 in 1 CARTONPASTE, DENTIFRICE17
69423-763-72Crest Pro HealthGum Detoxify and Restore Pro Deep Clean3 in 1 CELLO PACKPASTE, DENTIFRICE37
69423-763-85Crest Pro HealthGum Detoxify and Restore Pro Deep Clean1 in 1 CARTONPASTE, DENTIFRICE17
69423-763-85Crest Pro HealthGum Detoxify and Restore Pro Deep Clean24 g in 1 TUBEPASTE, DENTIFRICE247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-763CREST PRO HEALTH GUM DETOXIFY AND RESTORE PRO DEEP CLEAN (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, 12 package rows20250227_f4c3ad36-72d8-16e8-e053-2a95a90a8702.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
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNf4c3ad36-72d8-16e8-e053-2a95a90a87027
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDf4c3ad36-72d8-16e8-e053-2a95a90a87027
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYf4c3ad36-72d8-16e8-e053-2a95a90a87027
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYf4c3ad36-72d8-16e8-e053-2a95a90a87027
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYf4c3ad36-72d8-16e8-e053-2a95a90a87027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-763-13694230763133 CARTON in 1 CELLO PACK (69423-763-13) / 1 TUBE in 1 CARTON / 130 g in 1 TUBE3 carton2023-02-15NoNoCurrent
69423-763-25694230763251 TUBE in 1 CARTON (69423-763-25) / 70 g in 1 TUBE1 tube2023-02-15NoNoCurrent
69423-763-35694230763351 TUBE in 1 CARTON (69423-763-35) / 99 g in 1 TUBE1 tube2023-02-15NoNoCurrent
69423-763-46694230763461 TUBE in 1 CARTON (69423-763-46) / 130 g in 1 TUBE1 tube2023-02-15NoNoCurrent
69423-763-72694230763723 CARTON in 1 CELLO PACK (69423-763-72) / 1 TUBE in 1 CARTON / 99 g in 1 TUBE3 carton2023-02-15NoNoCurrent
69423-763-85694230763851 TUBE in 1 CARTON (69423-763-85) / 24 g in 1 TUBE1 tube2023-02-15NoNoCurrent