FDA.reportPublic FDA data

Crest Pro Health

Product NDC
69423-882
11-digit product format
694230882
Labeler code
69423
Product ID
69423-882_47e4a650-9481-bc12-e063-6294a90a695d
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
RINSE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
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 Pro Health
Brand name suffix
Densify Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

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
313029Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d84fb9f9-f2bc-358a-e053-2995a90abf07Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-882-32Crest Pro HealthDensify Rinse946 mL in 1 BOTTLE, PLASTICRINSE9467

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-882CREST PRO HEALTH DENSIFY RINSE (SODIUM FLUORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 1 package rows20250116_d84fb9f9-f2bc-358a-e053-2995a90abf07.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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company3bba340e-2a62-3b04-41b5-0ed9c13adb132026-04-22WarningsExact identifier
application number: M021
EverSmile SquirtSODIUM FLUORIDE 0.05%Everbrands, Inc.bc0ef174-2909-469a-b629-0eab4412bdfc2026-04-20WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmart41d6cc7a-0b87-e474-e063-6294a90ae9952026-04-20WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf2026-04-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEH E B8d40f693-083c-4eb6-9da1-42675d757e0e2026-04-16Warnings, Adverse reactionsExact identifier
application number: M021
Eversmile OrthoFoam Anticavity0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.9c12e792-94c8-4e29-9a54-e7e70aadade62026-04-16WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.6753b426-6d49-4438-a52f-c28e60a0e9d82026-04-16WarningsExact identifier
application number: M021
Osstem G Gum Health Care ToothSODIUM FLUORIDEOsstem Pharma Co., Ltd4f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Enamel StrengthSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4f6b8851-c778-8abd-e063-6294a90aef4f2026-04-14Exact identifier
application number: M021
Crest 3D White Stain Eraser Luxe MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6beb3b-2521-bfb7-e063-6394a90ad9ea2026-04-14Exact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d132026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6d11b2-5aa2-ab34-e063-6294a90ac0bc2026-04-14WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEPublix Super Markets, Inc.cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb2026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.f0e84078-499f-4a5a-bcd2-23f57805de862026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
Crest Pro-Health Advanced Multi-ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1cfc5b61-c8e5-943d-e063-6394a90a890b2026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Multi-Protection plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6f6299-f95f-2f0e-e063-6294a90a16412026-04-14WarningsExact identifier
application number: M021
Crest 3D White Strength Whitening Enamel ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f7125aa-3aa2-ca64-e063-6394a90a4cf32026-04-14WarningsExact identifier
application number: M021
Eversmile TheraFoam0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.57da2479-923a-45ec-8149-57b469b116372026-04-13WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company4f1d62ae-653e-3046-e063-6294a90abbf82026-04-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNd84fb9f9-f2bc-358a-e053-2995a90abf077
313029sodium fluoride 0.2 MG/ML MouthwashSCDd84fb9f9-f2bc-358a-e053-2995a90abf077
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYd84fb9f9-f2bc-358a-e053-2995a90abf077
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYd84fb9f9-f2bc-358a-e053-2995a90abf077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-882-3269423088232946 mL in 1 BOTTLE, PLASTIC (69423-882-32) 946 ml2022-01-010000-00-00NoNoCurrent