Crest

Product NDC
84126-643
11-digit product format
841260643
Labeler code
84126
Product ID
84126-643_4f2054af-bc20-2896-e063-6394a90a2bc9
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
2026-01-01
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
Clean Breath Smooth 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
4f2042b4-8eae-5c2c-e063-6394a90a640cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-643-03CrestClean Breath Smooth Mint93 g in 1 TUBEPASTE, DENTIFRICE931
84126-643-03CrestClean Breath Smooth Mint3 in 1 CARTONPASTE, DENTIFRICE31

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 35 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gerigentle-Good morningSODIUM FLORIDEGeri-Gentle Corporatione69b3767-00c5-a535-e053-2995a90ad2152025-10-23WarningsExact identifier
application number: M021
Hello Penguin ChillSODIUM FLUORIDEColgate-Palmolive Company5c47a7d5-da34-4658-8006-b36f6477cb9b2025-10-23WarningsExact identifier
application number: M021
Auraglow WhiteningSODIUM FLUORIDEAuraglow LLC9d45e436-92f6-4a9e-9b82-329847dca9ba2025-10-22WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyed20cf9d-6162-4337-bb0b-1a6a6e9e1dc32025-10-21WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitudede21b326-f885-464b-b2df-f3866a0b3e9a2025-10-20WarningsExact identifier
application number: M021
Target Kids Watermelon MintSODIUM FLUORIDETarget35bc2e4d-f1c7-438e-e063-6394a90aead02025-10-17WarningsExact identifier
application number: M021
MediChoice FluorideSODIUM MONOFLUOROPHOSPHATEO&M HALYARD, INC.a87956fa-8975-4a44-9e9a-4b2191e401fe2025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b6f893d-74ac-421e-a78b-f495ac425af02025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.a3e989f8-e6a2-4e13-8faa-77e95895166d2025-10-09WarningsExact identifier
application number: M021
TARGET UP AND UP ANTICAVITYSODIUM FLUORIDE 0.05%TARGET CORPORATION2992efce-1c66-df40-e063-6294a90ab3c02025-10-08WarningsExact identifier
application number: M021
MediChoice Premium Anticavity FluorideSODIUM FLUORIDEO&M HALYARD, INC.c6ba9b51-b958-4836-adc8-871529a43fc62025-10-08WarningsExact identifier
application number: M021
TidaloveSPICY CINNAMON TOOTHPASTE TABLETSParanmare LLC4092fcbf-27f7-b067-e063-6394a90a41c62025-10-07WarningsExact identifier
application number: M021
TidaloveCOOL MINT TOOTHPASTE TABLETSParanmare LLC4093060c-23a5-c77a-e063-6394a90a93042025-10-07WarningsExact identifier
application number: M021
TidaloveYUZU MINT TOOTHPASTE TABLETSParanmare LLC40946943-21cf-b114-e063-6394a90aed3f2025-10-07WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCfdb16e59-5be1-4bd0-a940-d542d67fb2df2025-10-02WarningsExact identifier
application number: M021
Intensive Enamel Repair Whitening TPINTENSIVE ENAMEL REPAIR WHITENING TPTopco Associates LLC3012a8da-7595-2f7c-e063-6294a90ae1202025-09-30WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INCb2ad2b19-6fdf-454d-9b1d-49b1c81016fd2025-09-30WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.a38363e6-7105-4663-95a0-09ecb2948f832025-09-30WarningsExact identifier
application number: M021
UNPA CHA CHA TOOTHPASTESODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fae966e-0246-b9f2-e063-6394a90a494c2025-09-26WarningsExact identifier
application number: M021
Cloveden ToothSODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fb01bea-7205-49ba-e063-6294a90a38412025-09-26WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN4f2042b4-8eae-5c2c-e063-6394a90a640c1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD4f2042b4-8eae-5c2c-e063-6394a90a640c1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY4f2042b4-8eae-5c2c-e063-6394a90a640c1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY4f2042b4-8eae-5c2c-e063-6394a90a640c1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY4f2042b4-8eae-5c2c-e063-6394a90a640c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-643-03841260643033 TUBE in 1 CARTON (84126-643-03) / 93 g in 1 TUBE3 tube2026-01-01NoNoCurrent