FDA.reportPublic FDA data

Crest Pro-Health

Product NDC
84126-649
11-digit product format
841260649
Labeler code
84126
Product ID
84126-649_4f6e3b36-e566-7d27-e063-6294a90ae5ac
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium chloride
Dosage form
RINSE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.014 g/20mL
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
Gum Restore Smooth Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.014 g/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100924Internal RxNorm lookup
1251371Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f6e3b36-e565-7d27-e063-6294a90ae5acAvailable 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
84126-649-01Crest Pro-HealthGum Restore Smooth 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 17 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
application number: M022
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
application number: M022
WinCo Foods Maximum Strength Oral AnalgesicBENZOCAINEWinCo Foods, LLCc22a7726-8c3f-41bf-b852-8456b2be6f932025-10-28WarningsExact identifier
application number: M022
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
application number: M022
LolliCaine Bubble GumBENZOCAINECentrix, Inc.56ae3a84-6bca-4906-a03d-9d755e1fba3b2025-10-24WarningsExact identifier
application number: M022
Diabetic Tussin Sore Throat CherryPHENOLMEDTECH PRODUCTS INCab351229-5771-4c6c-92a8-721cc41c002f2025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar FreeMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.34e4234c-ed61-4795-99fe-d281cdb0af882025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and CoughMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.6b1a50d0-be54-4fcb-b5e2-b47abf3555c02025-10-23WarningsExact identifier
application number: M022
Chloraseptic Childrens Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.38ff6922-1abe-4fa9-a74e-ede604f707b52025-10-23WarningsExact identifier
application number: M022
Boka SensitivePOTASSIUM NITRATEKaraka LLC40be9fab-53db-c67a-e063-6394a90a48cb2025-10-23WarningsExact identifier
application number: M022
Canker Care PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.1ec960db-52d5-4d99-a7f7-a2e538d287242025-10-20WarningsExact identifier
application number: M022
meijer Sensitive EXTRA WHITENINGPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bbcffb88-0bd4-4883-bb83-0b7a1428ad122025-10-20WarningsExact identifier
application number: M022
Quality Choice Maximum Strength Oral Pain RelievingBENZOCAINEChain Drug Marketing Association Incdbde8e7f-85d8-4083-b01a-3a7e410a77472025-10-17WarningsExact identifier
application number: M022
Quality ChoiceBENZOCAINEChain Drug Marketing Association, Inc.24c3c4a3-bd76-198d-e063-6394a90ad45a2025-10-16WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLCardinal Healthb84203bd-23e9-427d-83d8-f4c88266e23c2025-10-14WarningsExact identifier
application number: M022
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCe8a62f24-1db6-45fb-b6e1-5e57103f82bc2025-10-14WarningsExact identifier
application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINTPOTASSIUM NITRATE, SODIUM FLUORIDEAshtel Studios, Inc.bc74d2a6-fe34-44cf-b015-70ed4d47c9332025-10-13WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN4f6e3b36-e565-7d27-e063-6294a90ae5ac1
1251371Crest Pro-Health 0.07 % Oral RinsePSN4f6e3b36-e565-7d27-e063-6294a90ae5ac1
1251371cetylpyridinium chloride 0.7 MG/ML Mouthwash [Crest Mouthwash]SBD4f6e3b36-e565-7d27-e063-6294a90ae5ac1
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD4f6e3b36-e565-7d27-e063-6294a90ae5ac1
1100924cetylpyridinium chloride 0.07 % Oral RinseSY4f6e3b36-e565-7d27-e063-6294a90ae5ac1
1251371Crest 0.07 % MouthwashSY4f6e3b36-e565-7d27-e063-6294a90ae5ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-649-01841260649011000 mL in 1 BOTTLE, PLASTIC (84126-649-01) 1000 ml2026-01-01NoNoCurrent