FDA.reportPublic FDA data

Crest

Product NDC
69423-869
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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company3bba340e-2a62-3b04-41b5-0ed9c13adb132026-04-22WarningsExact identifier
application number: M021
EverSmile SquirtSODIUM FLUORIDE 0.05%Everbrands, Inc.bc0ef174-2909-469a-b629-0eab4412bdfc2026-04-20WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmart41d6cc7a-0b87-e474-e063-6294a90ae9952026-04-20WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf2026-04-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEH E B8d40f693-083c-4eb6-9da1-42675d757e0e2026-04-16Warnings, Adverse reactionsExact identifier
application number: M021
Eversmile OrthoFoam Anticavity0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.9c12e792-94c8-4e29-9a54-e7e70aadade62026-04-16WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.6753b426-6d49-4438-a52f-c28e60a0e9d82026-04-16WarningsExact identifier
application number: M021
Osstem G Gum Health Care ToothSODIUM FLUORIDEOsstem Pharma Co., Ltd4f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Enamel StrengthSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4f6b8851-c778-8abd-e063-6294a90aef4f2026-04-14Exact identifier
application number: M021
Crest 3D White Stain Eraser Luxe MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6beb3b-2521-bfb7-e063-6394a90ad9ea2026-04-14Exact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d132026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6d11b2-5aa2-ab34-e063-6294a90ac0bc2026-04-14WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEPublix Super Markets, Inc.cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb2026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.f0e84078-499f-4a5a-bcd2-23f57805de862026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
Crest Pro-Health Advanced Multi-ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1cfc5b61-c8e5-943d-e063-6394a90a890b2026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Multi-Protection plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6f6299-f95f-2f0e-e063-6294a90a16412026-04-14WarningsExact identifier
application number: M021
Crest 3D White Strength Whitening Enamel ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f7125aa-3aa2-ca64-e063-6394a90a4cf32026-04-14WarningsExact identifier
application number: M021
Eversmile TheraFoam0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.57da2479-923a-45ec-8149-57b469b116372026-04-13WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company4f1d62ae-653e-3046-e063-6294a90abbf82026-04-10WarningsExact 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 startMarketing endSampleExclude flagStatus
69423-869-03694230869033 CARTON in 1 CELLO PACK (69423-869-03) / 1 TUBE in 1 CARTON / 144 g in 1 TUBE3 carton2022-02-07NoNoCurrent
69423-869-08694230869085 CARTON in 1 CELLO PACK (69423-869-08) / 1 TUBE in 1 CARTON / 164 g in 1 TUBE5 carton2022-02-07NoNoCurrent
69423-869-32694230869322 CARTON in 1 CELLO PACK (69423-869-32) / 1 TUBE in 1 CARTON / 99 g in 1 TUBE2 carton2022-02-07NoNoCurrent
69423-869-33694230869333 CARTON in 1 CELLO PACK (69423-869-33) / 1 TUBE in 1 CARTON / 99 g in 1 TUBE3 carton2022-02-07NoNoCurrent
69423-869-35694230869351 TUBE in 1 CARTON (69423-869-35) / 99 g in 1 TUBE1 tube2022-02-070000-00-00NoNoCurrent
69423-869-51694230869511 TUBE in 1 CARTON (69423-869-51) / 144 g in 1 TUBE1 tube2022-02-070000-00-00NoNoCurrent
69423-869-52694230869522 CARTON in 1 CELLO PACK (69423-869-52) / 1 TUBE in 1 CARTON / 144 g in 1 TUBE2 carton2022-02-07NoNoCurrent
69423-869-55694230869555 CARTON in 1 CELLO PACK (69423-869-55) / 1 TUBE in 1 CARTON / 167 g in 1 TUBE5 carton2022-02-07NoNoCurrent
69423-869-59694230869591 TUBE in 1 CARTON (69423-869-59) / 167 g in 1 TUBE1 tube2022-02-07NoNoCurrent