FDA.reportPublic FDA data

Crest

Product NDC
69423-781
Requested package NDC
69423-781-59
11-digit product format
694230781
Labeler code
69423
Product ID
69423-781_47e36800-0672-cf64-e063-6294a90a85af
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 Clean Mint
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
fb466fb4-0915-a41f-e053-6294a90a2dfbAvailable 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
69423-781-03CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-03CrestPro Health Clean Mint85 g in 1 TUBEPASTE, DENTIFRICE8512
69423-781-04CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-04CrestPro Health Clean Mint4 in 1 CELLO PACKPASTE, DENTIFRICE412
69423-781-21CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-21CrestPro Health Clean Mint59 g in 1 TUBEPASTE, DENTIFRICE5912
69423-781-33CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-33CrestPro Health Clean Mint94 g in 1 TUBEPASTE, DENTIFRICE9412
69423-781-43CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-43CrestPro Health Clean Mint121 g in 1 TUBEPASTE, DENTIFRICE12112
69423-781-44CrestPro Health Clean Mint3 in 1 CARTONPASTE, DENTIFRICE312
69423-781-44CrestPro Health Clean Mint121 g in 1 TUBEPASTE, DENTIFRICE12112
69423-781-45CrestPro Health Clean Mint2 in 1 CARTONPASTE, DENTIFRICE212
69423-781-45CrestPro Health Clean Mint121 g in 1 TUBEPASTE, DENTIFRICE12112
69423-781-46CrestPro Health Clean Mint130 g in 1 TUBEPASTE, DENTIFRICE13012
69423-781-46CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-59CrestPro Health Clean Mint167 g in 1 TUBEPASTE, DENTIFRICE16712
69423-781-59CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-63CrestPro Health Clean Mint178 g in 1 TUBEPASTE, DENTIFRICE17812
69423-781-63CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-73CrestPro Health Clean Mint73 g in 1 TUBEPASTE, DENTIFRICE7312
69423-781-73CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112
69423-781-85CrestPro Health Clean Mint24 g in 1 TUBEPASTE, DENTIFRICE2412
69423-781-85CrestPro Health Clean Mint1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-781CREST PRO HEALTH CLEAN MINT (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, 24 package rows20250115_fb466fb4-0915-a41f-e053-6294a90a2dfb.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYfb466fb4-0915-a41f-e053-6294a90a2dfb12
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYfb466fb4-0915-a41f-e053-6294a90a2dfb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-781-59694230781591 TUBE in 1 CARTON (69423-781-59) / 167 g in 1 TUBE1 tube2022-10-03NoNoCurrent