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 22 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.ef63e193-5804-4b35-bae7-cad29cf4e8bc2026-01-12WarningsExact identifier
application number: M021
Prime Tooth Care BlueberrySODIUM FLUORIDEPrime Tooth Care LLC86642110-4572-4b8b-88f1-8d25fe05701e2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Juicy PeachSODIUM FLUORIDEPrime Tooth Care LLC142f1610-3494-459f-a956-760e82169b872026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Coconut WhipSODIUM FLUORIDEPrime Tooth Care LLC55e95657-9415-4d9c-ac9b-d021aa14e64d2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Hami MelonSODIUM FLUORIDEPrime Tooth Care LLC0028f88d-a9fe-4cfa-a6c6-168f9689b5f62026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Mango SmoothieSODIUM FLUORIDEPrime Tooth Care LLC2f2cf851-2edc-4aaf-9083-c37bc58547de2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care StrawberriesSODIUM FLUORIDEPrime Tooth Care LLC7b4328bd-5d2d-40ca-8322-5e818e1babf92026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Summer WatermelonSODIUM FLUORIDEPrime Tooth Care LLCb7c731a1-80e7-4571-a568-db0290a720c12026-01-09WarningsExact identifier
application number: M021
Kids Prime Pediatric Dental Group Anticavity for KidsSODIUM FLUORIDEPrime Tooth Care LLC93259174-447d-4f7a-8e55-990eb8da51512026-01-09WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Enamel ProtectSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf32d5708-8cb1-6499-e053-2995a90ac6322026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Complete Care Anticavity FluorideSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3a644c0-da04-276d-e053-2a95a90abf272026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Active RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4487d78-1da8-3f33-e053-2a95a90a6d922026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Sensitive CareSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf435c1fe-7fbb-1b25-e053-2995a90aca112026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Pro Intensive RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf45c9c89-f294-deca-e053-2a95a90ae5572026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a00de-b16a-66e6-e053-2995a90aedc62026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify Gentle WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a7dc7-77f3-3911-e053-2a95a90ad55c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon ExpressionsSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company961295a6-79ae-44b1-e053-2995a90a61302026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Intensive CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2118d-1216-d0d0-e053-2995a90a70882026-01-08WarningsExact identifier
application number: M021
Crest 3D White CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company96247083-39e9-7ca7-e053-2995a90a75d02026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Express WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2d5aa-b0e6-7068-e053-2995a90ae90c2026-01-08WarningsExact 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