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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDELidl US, LLCc47475aa-3125-410f-aa31-0add6e4ce1252026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf4c02924-95ee-09d2-e053-2995a90a81212026-02-03Exact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5d97011-7be3-3b1c-e053-2a95a90ade862026-02-03Exact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc.c28c3475-efbb-4099-83ab-ab91bac9dfc32026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEDemoulas Super Markets, Inc65abfb4d-3a1e-42df-b343-f270ce60a3bf2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company102e4d9c-0fae-d48a-e063-6294a90aac942026-02-03WarningsExact identifier
application number: M021
Crest Plus Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08767b0f-ed6e-8d32-e063-6294a90a10cd2026-02-03WarningsExact identifier
application number: M021
Crest Braces Care Anticavity Fluoride RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd8398cfd-9af6-690d-e053-2995a90a9b7c2026-02-03WarningsExact identifier
application number: M021
AutoBrush bubblegumSODIUM FLUORIDELander Enterprises, LLC2e85d6f7-2df8-4eb9-bc97-d7b7af7fb4602026-02-03WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLCd859d02d-a036-4d90-bed4-9a5c31e9e1ef2026-02-03WarningsExact identifier
application number: M021
Glowing WhiteSODIUM FLUORIDEDemoulas Super Markets, Inc32faf47d-b64f-4454-9f14-51503504c6b52026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Sodium fluorideSODIUM FLUORIDEDemoulas Super Markets, Inc2f5d3c75-1a11-47e1-b297-e2302177efe72026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc096e6a1d-316b-432a-bf27-70e8a13337cc2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d1932f-a85c-7b8f-e063-6394a90a6aca2026-02-02WarningsExact identifier
application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d4f96f-e61f-e6e6-e063-6294a90ab0a02026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Toy Story Wild West WatermelonSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d69901-0b07-b07d-e063-6394a90a3c342026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Frozen Blizzard BerrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6c1c9-cd21-cac6-e063-6294a90a81d62026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Princesses Grand GrapeSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6f926-da4e-26df-e063-6294a90a1c0c2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker PunchSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d70b88-d57c-37cd-e063-6294a90a4a592026-02-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERite Aid Corporation54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe2026-02-02Warnings, Adverse reactionsExact 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