FDA.reportPublic FDA data

Crest 3D White

Product NDC
84126-635
11-digit product format
841260635
Labeler code
84126
Product ID
84126-635_5514741a-cd50-062c-e063-6294a90a7d3a
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
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
Stain Eraser Daily Stain Prevention Icy Clean Mint
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
4f0b1d46-d52c-f409-e063-6394a90a5574Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-635-02Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint107 g in 1 TUBEPASTE, DENTIFRICE1072
84126-635-02Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint2 in 1 CARTONPASTE, DENTIFRICE22
84126-635-03Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint3 in 1 CELLO PACKPASTE, DENTIFRICE32
84126-635-03Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint1 in 1 CARTONPASTE, DENTIFRICE12
84126-635-27Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint1 in 1 CARTONPASTE, DENTIFRICE12
84126-635-27Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint76 g in 1 TUBEPASTE, DENTIFRICE762
84126-635-38Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint1 in 1 CARTONPASTE, DENTIFRICE12
84126-635-38Crest 3D WhiteStain Eraser Daily Stain Prevention Icy Clean Mint107 g in 1 TUBEPASTE, DENTIFRICE1072

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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4f0b1d46-d52c-f409-e063-6394a90a55742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-635-02841260635022 TUBE in 1 CARTON (84126-635-02) / 107 g in 1 TUBE2 tube2026-01-01NoNoCurrent
84126-635-03841260635033 CARTON in 1 CELLO PACK (84126-635-03) / 1 TUBE in 1 CARTON / 107 g in 1 TUBE3 carton2026-01-01NoNoCurrent
84126-635-27841260635271 TUBE in 1 CARTON (84126-635-27) / 76 g in 1 TUBE1 tube2026-01-01NoNoCurrent
84126-635-38841260635381 TUBE in 1 CARTON (84126-635-38) / 107 g in 1 TUBE1 tube2026-01-01NoNoCurrent