FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
84126-647
11-digit product format
841260647
Labeler code
84126
Product ID
84126-647_4f6d19bc-1178-aa97-e063-6294a90a017b
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
2026-01-01
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
Mouthwash Multi-Protection Strong Mint
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup
1658137Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f6d11b2-5aa2-ab34-e063-6294a90ac0bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-647-01Crest Pro-HealthMouthwash Multi-Protection Strong Mint1000 mL in 1 BOTTLE, PLASTICRINSE10001

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
1658137Crest 0.02 % MouthwashPSN4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
1658137sodium fluoride 0.2 MG/ML Mouthwash [Crest]SBD4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
313029sodium fluoride 0.2 MG/ML MouthwashSCD4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
1658137Crest 0.0219 % (fluoride ion 0.01 % ) Oral RinseSY4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
1658137Crest 0.2 MG/ML MouthwashSY4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
1658137Crest Pro-Health Advanced 0.02 % (0.01 % fluoride ion) MouthwashSY4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY4f6d11b2-5aa2-ab34-e063-6294a90ac0bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-647-01841260647011000 mL in 1 BOTTLE, PLASTIC (84126-647-01) 1000 ml2026-01-01NoNoCurrent