FDA.reportPublic FDA data

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 firm2026-10-15
excluded packagepackage69423-76569423-765-28DDiscontinued 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 · 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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact 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