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 38 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL WHITENING SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35839b10-4c40-40e5-e063-6294a90a85b42025-05-19WarningsExact identifier
application number: M021
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride Cotton CandySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC25f182cb-ad1e-4c13-bc79-1ec251754cf82025-05-12WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride WatermelonSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb506df13-649f-4615-bc25-6ae08bd56b182025-05-12WarningsExact identifier
application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.3de0d71a-7704-97dd-e063-6294a90a5d2c2025-05-01WarningsExact identifier
application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus ScopeSODIUM FLUORIDENavajo Manufacturing Company Inc3adb1524-0fd6-4728-b757-dcbda4cdd0fb2025-04-29WarningsExact identifier
application number: M021
Listerine Clinical Solutions Enamel Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC11e1c1d0-465b-9e14-e063-6394a90a8cdd2025-04-22WarningsExact identifier
application number: M021
Hello Mighty Multi taskerSTANNOUS FLUORIDEColgate-Palmolive Company48e36e06-3666-9032-b9c8-4be035e751f22025-04-15WarningsExact identifier
application number: M021
Hello Kids Wild Strawberry Wild StrawberrySODIUM FLUORIDEColgate-Palmolive Company39dddf11-45a0-b883-e12f-d80c582e8c892025-04-15WarningsExact identifier
application number: M021
Hello Magical MermaidSODIUM FLUORIDEColgate-Palmolive Companybdabf74f-8d1e-0f11-159a-0025bcd0ca3e2025-04-15WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.300303e7-ef8b-7449-e063-6294a90ac8112025-04-09WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.303d4ad0-5a2b-347a-e063-6394a90aa0ba2025-04-07WarningsExact identifier
application number: M021
OralLine KidsSODIUM FLUORIDEJ.M. Murray Center Inc.12c5bee5-e228-4f71-9bfd-c377ee2372a92025-03-21WarningsExact identifier
application number: M021
AdoptaPlatoonSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDc1592b56-cf3d-4a4d-be84-e40eb3f1456e2025-03-21WarningsExact identifier
application number: M021
OralLine SecureSODIUM FLUORIDEJ.M. Murray Center Inc.4c0970e9-7417-4234-89e3-3b602a609af52025-03-20WarningsExact identifier
application number: M021
smart way MINT cavity protectionSODIUM MONOFLUOROPHOSPHATEThe Kroger Co.45cc7a60-b4a7-4263-a114-f0d1f98a87fc2025-03-19WarningsExact identifier
application number: M021
HismileMAGICALLY DELICIOUS FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd309366f8-6a52-fe9f-e063-6394a90a5de32025-03-18WarningsExact identifier
application number: M021
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2025-03-13WarningsExact identifier
application number: M021
Hismile Pink Lemonade Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b92ff92-3722-3702-e063-6394a90a38b02025-03-13WarningsExact 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