FDA.reportPublic FDA data

Crest Cavity Protection

Product NDC
69423-815
11-digit product format
694230815
Labeler code
69423
Product ID
69423-815_49ef9a5d-2bd1-2d93-e063-6394a90a3fe3
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
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 Cavity Protection
Brand name suffix
Cool Mint Gel
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
102e4d9c-0fae-d48a-e063-6294a90aac94Available 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
69423-815-11Crest Cavity ProtectionCool Mint Gel2 in 1 CARTONGEL, DENTIFRICE210
69423-815-11Crest Cavity ProtectionCool Mint Gel161 g in 1 TUBEGEL, DENTIFRICE16110
69423-815-24Crest Cavity ProtectionCool Mint Gel68 g in 1 TUBEGEL, DENTIFRICE6810
69423-815-24Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110
69423-815-35Crest Cavity ProtectionCool Mint Gel3 in 1 CARTONGEL, DENTIFRICE310
69423-815-35Crest Cavity ProtectionCool Mint Gel161 g in 1 TUBEGEL, DENTIFRICE16110
69423-815-42Crest Cavity ProtectionCool Mint Gel119 g in 1 TUBEGEL, DENTIFRICE11910
69423-815-42Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110
69423-815-57Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110
69423-815-57Crest Cavity ProtectionCool Mint Gel161 g in 1 TUBEGEL, DENTIFRICE16110
69423-815-82Crest Cavity ProtectionCool Mint Gel232 g in 1 TUBEGEL, DENTIFRICE23210
69423-815-82Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110
69423-815-85Crest Cavity ProtectionCool Mint Gel1 in 1 CARTONGEL, DENTIFRICE110
69423-815-85Crest Cavity ProtectionCool Mint Gel24 g in 1 TUBEGEL, DENTIFRICE2410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-815CREST CAVITY PROTECTION COOL MINT GEL (SODIUM FLUORIDE) GEL, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, 14 package rows20250227_102e4d9c-0fae-d48a-e063-6294a90aac94.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 49 of 50 · 995 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 % ToothpastePSN102e4d9c-0fae-d48a-e063-6294a90aac9410
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD102e4d9c-0fae-d48a-e063-6294a90aac9410
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY102e4d9c-0fae-d48a-e063-6294a90aac9410
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY102e4d9c-0fae-d48a-e063-6294a90aac9410
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY102e4d9c-0fae-d48a-e063-6294a90aac9410
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY102e4d9c-0fae-d48a-e063-6294a90aac9410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-815-11694230815112 TUBE in 1 CARTON (69423-815-11) / 161 g in 1 TUBE2 tube2023-01-01NoNoCurrent
69423-815-24694230815241 TUBE in 1 CARTON (69423-815-24) / 68 g in 1 TUBE1 tube2023-01-01NoNoCurrent
69423-815-35694230815353 TUBE in 1 CARTON (69423-815-35) / 161 g in 1 TUBE3 tube2023-01-01NoNoCurrent
69423-815-42694230815421 TUBE in 1 CARTON (69423-815-42) / 119 g in 1 TUBE1 tube2023-01-01NoNoCurrent
69423-815-57694230815571 TUBE in 1 CARTON (69423-815-57) / 161 g in 1 TUBE1 tube2023-11-13NoNoCurrent
69423-815-82694230815821 TUBE in 1 CARTON (69423-815-82) / 232 g in 1 TUBE1 tube2023-11-13NoNoCurrent
69423-815-85694230815851 TUBE in 1 CARTON (69423-815-85) / 24 g in 1 TUBE1 tube2023-01-01NoNoCurrent