FDA.reportPublic FDA data

Crest 3D White

Product NDC
69423-836
11-digit product format
694230836
Labeler code
69423
Product ID
69423-836_47e5179c-5fa2-860c-e063-6294a90a6462
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Procter & Gamble Manfuacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
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 Deep Clean
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
128613c4-c06b-bdf5-e063-6294a90acd34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-836-23Crest 3D WhiteAdvanced Deep Clean93 g in 1 TUBEPASTE, DENTIFRICE936
69423-836-23Crest 3D WhiteAdvanced Deep Clean2 in 1 CARTONPASTE, DENTIFRICE26
69423-836-28Crest 3D WhiteAdvanced Deep Clean107 g in 1 TUBEPASTE, DENTIFRICE1076
69423-836-28Crest 3D WhiteAdvanced Deep Clean2 in 1 CARTONPASTE, DENTIFRICE26
69423-836-33Crest 3D WhiteAdvanced Deep Clean1 in 1 CARTONPASTE, DENTIFRICE16
69423-836-33Crest 3D WhiteAdvanced Deep Clean93 g in 1 TUBEPASTE, DENTIFRICE936
69423-836-38Crest 3D WhiteAdvanced Deep Clean107 g in 1 TUBEPASTE, DENTIFRICE1076
69423-836-38Crest 3D WhiteAdvanced Deep Clean1 in 1 CARTONPASTE, DENTIFRICE16
69423-836-66Crest 3D WhiteAdvanced Deep Clean1 in 1 CARTONPASTE, DENTIFRICE16
69423-836-66Crest 3D WhiteAdvanced Deep Clean187 g in 1 TUBEPASTE, DENTIFRICE1876

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-836CREST 3D WHITE ADVANCED DEEP CLEAN (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANFUACTURING COMPANY]3Current NDC, 10 package rows20250116_128613c4-c06b-bdf5-e063-6294a90acd34.zip

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 48 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY128613c4-c06b-bdf5-e063-6294a90acd346

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-836-23694230836232 TUBE in 1 CARTON (69423-836-23) / 93 g in 1 TUBE2 tube2019-07-01NoNoCurrent
69423-836-28694230836282 TUBE in 1 CARTON (69423-836-28) / 107 g in 1 TUBE2 tube2019-07-01NoNoCurrent
69423-836-33694230836331 TUBE in 1 CARTON (69423-836-33) / 93 g in 1 TUBE1 tube2019-07-01NoNoCurrent
69423-836-38694230836381 TUBE in 1 CARTON (69423-836-38) / 107 g in 1 TUBE1 tube2019-07-01NoNoCurrent
69423-836-66694230836661 TUBE in 1 CARTON (69423-836-66) / 187 g in 1 TUBE1 tube2025-04-01NoNoCurrent