FDA.reportPublic FDA data

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 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc5d5bc17-e81b-34aa-e053-2a95a90ad77f2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc5745cc4-213d-1dde-e053-2995a90af5622026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960fef18-4533-5250-e053-2995a90aaf762026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc574b51d-07bd-b363-e053-2995a90a7c0e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance BlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d9a1754-8d38-054f-e053-2991aa0a46532026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Breath Purify and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc60fdacf-d997-19a5-e053-2a95a90a96a32026-01-08WarningsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d7fffb9-47e0-73cd-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
application number: M021
Crest Gum Detoxify plus WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company63779942-0f6c-11c5-e053-2991aa0a25ab2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Sensitivity Active FoamSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Companyb8535d1c-cf15-f353-e053-2a95a90a79742026-01-08WarningsExact identifier
application number: M021
Burts Bees Extra White Zen PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Company81279e1f-6224-8114-e053-2991aa0aab082026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc74229c4-b095-df32-e053-2a95a90a4aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyc8350ab3-9347-58c0-e053-2995a90a72382026-01-08Exact identifier
application number: M021
Crest Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyddcb0871-9900-125f-e053-2a95a90a75de2026-01-08Exact identifier
application number: M021
Burts Bees Deep Clean plus WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc924b8dd-8d84-1329-e053-2995a90a45312026-01-08WarningsExact identifier
application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company07ed767e-225c-e9c5-e063-6394a90af9312026-01-08WarningsExact identifier
application number: M021
Crest Plus Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company0813171e-bda5-b004-e063-6394a90ad3642026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Company087b3434-2636-74ce-e063-6394a90a25ad2026-01-08WarningsExact 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