FDA.reportPublic FDA data

Crest Pro-Health Advanced Complete Care

Product NDC
69423-751
11-digit product format
694230751
Labeler code
69423
Product ID
69423-751_47e28064-055e-b334-e063-6394a90a3252
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
2023-01-02
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 Advanced Complete Care
Brand name suffix
Anticavity Fluoride
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
f3a644c0-da04-276d-e053-2a95a90abf27Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-751-01Crest Pro-Health Advanced Complete CareAnticavity Fluoride1000 mL in 1 BOTTLE, PLASTICRINSE10007
69423-751-03Crest Pro-Health Advanced Complete CareAnticavity Fluoride1000 mL in 1 BOTTLE, PLASTICRINSE10007
69423-751-03Crest Pro-Health Advanced Complete CareAnticavity Fluoride3 in 1 CELLO PACKRINSE37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-751CREST PRO-HEALTH ADVANCED COMPLETE CARE ANTICAVITY FLUORIDE (SODIUM FLUORIDE) RINSE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, 3 package rows20250115_f3a644c0-da04-276d-e053-2a95a90abf27.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 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc5d5bc17-e81b-34aa-e053-2a95a90ad77f2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc5745cc4-213d-1dde-e053-2995a90af5622026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960fef18-4533-5250-e053-2995a90aaf762026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc574b51d-07bd-b363-e053-2995a90a7c0e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance BlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d9a1754-8d38-054f-e053-2991aa0a46532026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Breath Purify and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc60fdacf-d997-19a5-e053-2a95a90a96a32026-01-08WarningsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d7fffb9-47e0-73cd-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
application number: M021
Crest Gum Detoxify plus WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company63779942-0f6c-11c5-e053-2991aa0a25ab2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Sensitivity Active FoamSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Companyb8535d1c-cf15-f353-e053-2a95a90a79742026-01-08WarningsExact identifier
application number: M021
Burts Bees Extra White Zen PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Company81279e1f-6224-8114-e053-2991aa0aab082026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc74229c4-b095-df32-e053-2a95a90a4aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyc8350ab3-9347-58c0-e053-2995a90a72382026-01-08Exact identifier
application number: M021
Crest Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyddcb0871-9900-125f-e053-2a95a90a75de2026-01-08Exact identifier
application number: M021
Burts Bees Deep Clean plus WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc924b8dd-8d84-1329-e053-2995a90a45312026-01-08WarningsExact identifier
application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company07ed767e-225c-e9c5-e063-6394a90af9312026-01-08WarningsExact identifier
application number: M021
Crest Plus Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company0813171e-bda5-b004-e063-6394a90ad3642026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Company087b3434-2636-74ce-e063-6394a90a25ad2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNf3a644c0-da04-276d-e053-2a95a90abf277
313029sodium fluoride 0.2 MG/ML MouthwashSCDf3a644c0-da04-276d-e053-2a95a90abf277
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYf3a644c0-da04-276d-e053-2a95a90abf277
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYf3a644c0-da04-276d-e053-2a95a90abf277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-751-01694230751011000 mL in 1 BOTTLE, PLASTIC (69423-751-01) 1000 ml2023-02-01NoNoCurrent
69423-751-03694230751033 BOTTLE, PLASTIC in 1 CELLO PACK (69423-751-03) / 1000 mL in 1 BOTTLE, PLASTIC2023-01-02NoNoCurrent