FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-628
11-digit product format
841260628
Labeler code
84126
Product ID
84126-628_4f08260b-c544-87ed-e063-6394a90a3639
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium 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
SODIUM 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 3D White
Brand name suffix
Advanced Arctic Fresh with Stain-Blasting Foam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ef4146d-6281-fe66-e063-6394a90a32c3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-628-04Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam2 in 1 CELLO PACKPASTE, DENTIFRICE23
84126-628-04Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-05Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-05Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam2 in 1 CELLO PACKPASTE, DENTIFRICE23
84126-628-06Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-06Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam3 in 1 CELLO PACKPASTE, DENTIFRICE33
84126-628-24Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam68 g in 1 TUBEPASTE, DENTIFRICE683
84126-628-24Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-33Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13
84126-628-33Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam93 g in 1 TUBEPASTE, DENTIFRICE933
84126-628-49Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam139 g in 1 TUBEPASTE, DENTIFRICE1393
84126-628-49Crest 3D WhiteAdvanced Arctic Fresh with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE13

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 23 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c82742-fb27-62a2-e053-2a95a90aa7c42026-01-08WarningsExact identifier
application number: M021
Native WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companya5248d35-f488-3457-e053-2995a90a411e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Companyb7882679-339c-554f-e053-2995a90afa7f2026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6f9a813-7ed6-895c-e053-2995a90a9ea62026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Dual Blast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb788d16a-8a58-0352-e053-2a95a90a965e2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Outlast Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb789587e-7f49-163a-e053-2a95a90a823f2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Advanced Whitening Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb81a22dc-b759-24cd-e053-2995a90a91482026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4ef4146d-6281-fe66-e063-6394a90a32c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-628-04841260628042 CARTON in 1 CELLO PACK (84126-628-04) / 1 TUBE in 1 CARTON / 68 g in 1 TUBE2 carton2026-01-01NoNoCurrent
84126-628-05841260628052 CARTON in 1 CELLO PACK (84126-628-05) / 1 TUBE in 1 CARTON / 93 g in 1 TUBE2 carton2026-01-01NoNoCurrent
84126-628-06841260628063 CARTON in 1 CELLO PACK (84126-628-06) / 1 TUBE in 1 CARTON / 93 g in 1 TUBE3 carton2026-01-01NoNoCurrent
84126-628-24841260628241 TUBE in 1 CARTON (84126-628-24) / 68 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-628-33841260628331 TUBE in 1 CARTON (84126-628-33) / 93 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-628-49841260628491 TUBE in 1 CARTON (84126-628-49) / 139 g in 1 TUBE1 tube2026-01-01NoNoCurrent