FDA.reportPublic FDA data

Listerine Essential Care

Product NDC
69968-0701
11-digit product format
699680701
Labeler code
69968
Product ID
69968-0701_40c937f3-618c-1c3d-e063-6294a90a35cf
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
GEL, DENTIFRICE
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-03
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.3 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listerine Essential Care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
90b5c3d8-baa4-44ab-8f73-e177007f0219Available 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
69968-0701-4Listerine Essential Care119 g in 1 TUBEGEL, DENTIFRICE1195
69968-0701-4Listerine Essential Care1 in 1 CARTONGEL, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0701LISTERINE ESSENTIAL CARE (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241114_90b5c3d8-baa4-44ab-8f73-e177007f0219.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 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.fc86b98e-d556-4769-e053-6394a90afc6e2026-01-08WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales1b6618ea-6533-41d7-be2c-13bb9e108dc52026-01-08WarningsExact identifier
application number: M022
equate SensitivePOTASSIUM NITRATE, SODIUM FLUORIDEWal-Mart Stores Inc79899b59-3a16-6504-e053-2991aa0a895a2026-01-08WarningsExact identifier
application number: M022
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.451283d3-78b0-8361-e063-6294a90a1fd52026-01-08WarningsExact identifier
application number: M022
CVS Maximum StrengthBENZOCAINECVS Pharmacy8691d6b6-741e-47b2-8332-76742b34715f2026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
application number: M022
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
application number: M022
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
application number: M022
Sootheez Organic Wild CherryPECTINBFY LLC47baa2a8-270c-fa07-e063-6394a90a97f62026-01-06WarningsExact identifier
application number: M022
Parodontax Gum Strengthen and ProtectCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC3bb378c8-14b2-aa13-e063-6294a90a4db32026-01-05WarningsExact identifier
application number: M022
MySweetSmile Toothpaste.MYSWEETSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478baf87-9276-7288-e063-6294a90a9e8e2026-01-04WarningsExact identifier
application number: M022
MySweetSmile Mango Toothpaste.MYSWEETSMILE MANGO TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cbdeb-28e1-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M022
Smile PaintSODIUM FLUORIDEJABBER JAW KIDS TOOTHPASTE LLCa7463b5c-53b2-4353-a5ea-800fbd7bd17d2026-01-02WarningsExact identifier
application number: M022
Dentek Canker CoverMENTHOLBershtel Enterprises2669183c-7a58-037e-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M022
AutoBrush strawberrySODIUM FLUORIDELander Enterprises, LLC05929148-bffe-439f-a9d4-3170816c0fa22025-12-31WarningsExact identifier
application number: M022
AutoBrush WatermelonSODIUM FLUORIDELander Enterprises, LLC37a4e712-e3b5-42f6-971c-98dea4b8dd062025-12-31WarningsExact identifier
application number: M022
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC6bcd35f5-18ea-4fc8-84cd-06db73f38a1e2025-12-31WarningsExact identifier
application number: M022
AutoBrush BubblegumSODIUM FLUORIDELander Enterprises, LLCe7bf7e31-650d-4a1c-9100-48722344b2012025-12-31WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
application number: M022
Sensitive Mint Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.1e5e8b24-8304-482c-ae80-73effcc345da2025-12-23WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN90b5c3d8-baa4-44ab-8f73-e177007f02195
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD90b5c3d8-baa4-44ab-8f73-e177007f02195
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY90b5c3d8-baa4-44ab-8f73-e177007f02195
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY90b5c3d8-baa4-44ab-8f73-e177007f02195
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY90b5c3d8-baa4-44ab-8f73-e177007f02195
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY90b5c3d8-baa4-44ab-8f73-e177007f02195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0701-4699680701041 TUBE in 1 CARTON (69968-0701-4) / 119 g in 1 TUBE1 tube2021-03-030000-00-00NoNoCurrent