FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-634
11-digit product format
841260634
Labeler code
84126
Product ID
84126-634_4f0896e8-3eb6-fa20-e063-6394a90a728c
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 Charcoal 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
4ef57a05-b9f5-42f7-e063-6294a90a5d89Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-634-03Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam3 in 1 CELLO PACKPASTE, DENTIFRICE32
84126-634-03Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE12
84126-634-23Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam68 g in 1 TUBEPASTE, DENTIFRICE682
84126-634-23Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam2 in 1 CARTONPASTE, DENTIFRICE22
84126-634-24Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam68 g in 1 TUBEPASTE, DENTIFRICE682
84126-634-24Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE12
84126-634-33Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam1 in 1 CARTONPASTE, DENTIFRICE12
84126-634-33Crest 3D WhiteAdvanced Charcoal with Stain-Blasting Foam93 g in 1 TUBEPASTE, DENTIFRICE932

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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN4ef57a05-b9f5-42f7-e063-6294a90a5d892
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4ef57a05-b9f5-42f7-e063-6294a90a5d892
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4ef57a05-b9f5-42f7-e063-6294a90a5d892
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4ef57a05-b9f5-42f7-e063-6294a90a5d892
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4ef57a05-b9f5-42f7-e063-6294a90a5d892
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4ef57a05-b9f5-42f7-e063-6294a90a5d892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-634-03841260634033 CARTON in 1 CELLO PACK (84126-634-03) / 1 TUBE in 1 CARTON / 93 g in 1 TUBE3 carton2026-01-01NoNoCurrent
84126-634-23841260634232 TUBE in 1 CARTON (84126-634-23) / 68 g in 1 TUBE2 tube2026-01-01NoNoCurrent
84126-634-24841260634241 TUBE in 1 CARTON (84126-634-24) / 68 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-634-33841260634331 TUBE in 1 CARTON (84126-634-33) / 93 g in 1 TUBE1 tube2026-01-01NoNoCurrent