FDA.reportPublic FDA data

Crest

Product NDC
69423-784
11-digit product format
694230784
Labeler code
69423
Product ID
69423-784_47e3b02c-04cd-3f66-e063-6294a90a85a7
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
2022-10-03
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
Brand name suffix
Pro Health with a Touch of Scope
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
fb572b41-36cd-55d7-e053-6394a90a71c8Available 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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-784-02CrestPro Health with a Touch of Scope1 in 1 CARTONPASTE, DENTIFRICE17
69423-784-02CrestPro Health with a Touch of Scope2 in 1 CELLO PACKPASTE, DENTIFRICE27
69423-784-03CrestPro Health with a Touch of Scope3 in 1 CELLO PACKPASTE, DENTIFRICE37
69423-784-03CrestPro Health with a Touch of Scope1 in 1 CARTONPASTE, DENTIFRICE17
69423-784-21CrestPro Health with a Touch of Scope1 in 1 CARTONPASTE, DENTIFRICE17
69423-784-21CrestPro Health with a Touch of Scope59 g in 1 TUBEPASTE, DENTIFRICE597
69423-784-43CrestPro Health with a Touch of Scope121 g in 1 TUBEPASTE, DENTIFRICE1217
69423-784-43CrestPro Health with a Touch of Scope1 in 1 CARTONPASTE, DENTIFRICE17
69423-784-46CrestPro Health with a Touch of Scope130 g in 1 TUBEPASTE, DENTIFRICE1307
69423-784-46CrestPro Health with a Touch of Scope1 in 1 CARTONPASTE, DENTIFRICE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-784CREST PRO HEALTH WITH A TOUCH OF SCOPE (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 10 package rows20250321_fb572b41-36cd-55d7-e053-6394a90a71c8.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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact identifier
application number: M021
Advance White Tartar Control Breath FresheningSODIUM FLUORIDEChurch & Dwight Co., Inc.aa8be8f5-ba46-4b1b-afaa-58fddf8f87802024-11-20WarningsExact identifier
application number: M021
Enamel DefenseSODIUM FLUORIDEChurch & Dwight Co., Inc.9e8f1ce9-b161-50db-e053-2995a90ad32b2024-11-20WarningsExact identifier
application number: M021
Rembrandt Deeply White Plus PeroxideSODIUM MONOFLUOROPHOSPHATERanir LLCbf7da007-ab9d-4631-bc28-6ca245fd62652024-11-20WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNfb572b41-36cd-55d7-e053-6394a90a71c87
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDfb572b41-36cd-55d7-e053-6394a90a71c87
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYfb572b41-36cd-55d7-e053-6394a90a71c87
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYfb572b41-36cd-55d7-e053-6394a90a71c87
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYfb572b41-36cd-55d7-e053-6394a90a71c87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-784-02694230784022 CARTON in 1 CELLO PACK (69423-784-02) / 1 TUBE in 1 CARTON / 121 g in 1 TUBE2 carton2025-01-01NoNoCurrent
69423-784-03694230784033 CARTON in 1 CELLO PACK (69423-784-03) / 1 TUBE in 1 CARTON / 121 g in 1 TUBE3 carton2025-01-01NoNoCurrent
69423-784-21694230784211 TUBE in 1 CARTON (69423-784-21) / 59 g in 1 TUBE1 tube2025-07-01NoNoCurrent
69423-784-43694230784431 TUBE in 1 CARTON (69423-784-43) / 121 g in 1 TUBE1 tube2022-10-03NoNoCurrent
69423-784-46694230784461 TUBE in 1 CARTON (69423-784-46) / 130 g in 1 TUBE1 tube2022-10-03NoNoCurrent