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 34 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Whipped Mellow Mint Dream FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company7a72b687-475d-437a-9734-a29637e5516a2025-11-11WarningsExact identifier
application number: M021
Spry DentifriceTOOTHPASTEXlear Inc.43567bbc-b07e-b605-e063-6294a90aad782025-11-11WarningsExact identifier
application number: M021
Hello Naturally WhiteningSODIUM MONOFLUOROPHOSPHATECOLGATE PALMOLIVE COMPANY5ad241e1-6bfc-7863-6a7a-100753651f0a2025-11-11WarningsExact identifier
application number: M021
Hello Whipped Peppermint Stick FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyd6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f8132025-11-11WarningsExact identifier
application number: M021
Super MintMINT TOOTHPASTESuperMouth, LLC.d23e89f5-7b65-4ed9-803a-38233f30d8f22025-11-07WarningsExact identifier
application number: M021
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.51f1d84c-809a-4c96-a117-7a8d8aa1e6b42025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.c44686f8-93ee-4a8f-8481-3439d123f6d22025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.16ebcb37-5703-4e10-b965-570e18434b522025-11-04WarningsExact identifier
application number: M021
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65fa41e-ce2e-53e4-e053-2995a90a24d22025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65c62d9-e8a6-3101-e053-2995a90a14942025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.15bdc03e-2cc7-4b7d-96fc-4f3236ed5c752025-11-04WarningsExact identifier
application number: M021
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
application number: M021
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
application number: M021
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
application number: M021
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
application number: M021
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
application number: M021
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
application number: M021
PERIOE KAKAO KIDS StrawberrySODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.4239f8c2-a5f5-3fa6-e063-6294a90acb472025-10-28WarningsExact 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