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 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 % 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