FDA.reportPublic FDA data

Crest

Product NDC
69423-869
Requested package NDC
69423-869-55
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 37 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact 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
69423-869-55694230869555 CARTON in 1 CELLO PACK (69423-869-55) / 1 TUBE in 1 CARTON / 167 g in 1 TUBE5 carton2022-02-07NoNoCurrent