FDA.reportPublic FDA data

Crest

Product NDC
69423-869
Requested package NDC
69423-869-32
11-digit product format
694230869
Labeler code
69423
Product ID
69423-869_47e499e7-cff9-8a21-e063-6294a90a2765
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
2022-02-07
Substance
STANNOUS FLUORIDE
Active strength
1.6 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 Advanced Deep Clean Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.6 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
d774295f-8ebd-9877-e053-2a95a90a9a0eAvailable 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
69423-869-03CrestPro Health Advanced Deep Clean Mint3 in 1 CELLO PACKPASTE, DENTIFRICE310
69423-869-03CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-08CrestPro Health Advanced Deep Clean Mint5 in 1 CELLO PACKPASTE, DENTIFRICE510
69423-869-08CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-32CrestPro Health Advanced Deep Clean Mint2 in 1 CELLO PACKPASTE, DENTIFRICE210
69423-869-32CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-33CrestPro Health Advanced Deep Clean Mint3 in 1 CELLO PACKPASTE, DENTIFRICE310
69423-869-33CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-35CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-35CrestPro Health Advanced Deep Clean Mint99 g in 1 TUBEPASTE, DENTIFRICE9910
69423-869-51CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-51CrestPro Health Advanced Deep Clean Mint144 g in 1 TUBEPASTE, DENTIFRICE14410
69423-869-52CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-52CrestPro Health Advanced Deep Clean Mint2 in 1 CELLO PACKPASTE, DENTIFRICE210
69423-869-55CrestPro Health Advanced Deep Clean Mint5 in 1 CELLO PACKPASTE, DENTIFRICE510
69423-869-55CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-59CrestPro Health Advanced Deep Clean Mint1 in 1 CARTONPASTE, DENTIFRICE110
69423-869-59CrestPro Health Advanced Deep Clean Mint167 g in 1 TUBEPASTE, DENTIFRICE16710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-869CREST PRO HEALTH ADVANCED DEEP CLEAN MINT (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, Legacy NDC, 18 package rows20250125_d774295f-8ebd-9877-e053-2a95a90a9a0e.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 % ) ToothpastePSNd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYd774295f-8ebd-9877-e053-2a95a90a9a0e10
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYd774295f-8ebd-9877-e053-2a95a90a9a0e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-869-32694230869322 CARTON in 1 CELLO PACK (69423-869-32) / 1 TUBE in 1 CARTON / 99 g in 1 TUBE2 carton2022-02-07NoNoCurrent