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 20 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
application number: M022
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
application number: M022
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact 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