FDA.reportPublic FDA data

Meijer Enamel Guard

Product NDC
41250-514
11-digit product format
412500514
Labeler code
41250
Product ID
41250-514_3bdd868d-4c0f-0942-e063-6294a90a6d15
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Meijer Distribution Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-25
Marketing end
2028-03-31
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
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
Meijer Enamel Guard

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82bc95be-0a07-3f00-e053-2a91aa0a7438Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-514-09Meijer Enamel Guard1 in 1 CARTONPASTE, DENTIFRICE124
41250-514-09Meijer Enamel Guard113 g in 1 TUBEPASTE, DENTIFRICE11324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-514MEIJER ENAMEL GUARD (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [MEIJER DISTRIBUTION INC]22Current NDC, Legacy NDC, 2 package rows20250119_82bc95be-0a07-3f00-e053-2a91aa0a7438.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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries BlueberryFLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRYWORLD DENTISTS ASSOCIATION AMERICA LIMITED3573f149-2af9-4c86-e063-6294a90a7b3f2025-05-18WarningsExact identifier
application number: M022
Bubble Gum Flavor For Kids 25g 50gBUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50GWORLD DENTISTS ASSOCIATION AMERICA LIMITED354c1eda-ec5b-a8c7-e063-6294a90a871d2025-05-16WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDESafeway, Inc.8fe2f1df-3264-455d-b62c-953dce171c022025-05-16WarningsExact identifier
application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath FreshenerCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC32b632bf-058d-447b-a7fb-a9dd05c1e2b82025-05-08WarningsExact identifier
application number: M022
Parodontax Active Gum Health Clear MintCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC444f931d-5e38-4cda-97ba-98aa0b5fe4f62025-05-08WarningsExact identifier
application number: M022
Listerine Clinical Solutions Gum Health Icy MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC06e1122b-1100-43c0-e063-6394a90a2e782025-04-22WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEStrategic Sourcing Services LLC5260258a-bb1e-43d6-bce1-70a38778a64a2025-04-14WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDETARGET Corporation93d0bb3a-51d3-44c8-8fb7-bdb82adfbb652025-04-14WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee467ec4-bd5e-644a-e053-2a95a90ac2732025-04-10WarningsExact identifier
application number: M022
MouthwashMENTHOL, METHYL SALICYLATE, THYMOLOrazen Inc873c43df-1d46-359b-e053-2a91aa0a43192025-04-07WarningsExact identifier
application number: M022
Sensodyne Complete Protection Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLCe3cc3146-8aed-4f6b-a252-e379418c2b8d2025-03-26WarningsExact identifier
application number: M022
Listerine Freshburst AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee1e1df9-74c6-d24b-e053-2a95a90a43d32025-03-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCedb9e374-4dba-5823-e053-2a95a90a3da52025-03-03WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEGood Sense (Geiss, Destin & Dunn, Inc.)cfe9be26-e4a4-413c-a602-2f5948e3bb7a2025-03-03WarningsExact identifier
application number: M022
LISTERINE Original AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC78e2e172-09a4-4bf1-9871-d099c49087be2025-02-28WarningsExact identifier
application number: M022
WHITE GLO CHARCOAL SENSITIVEPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa5edb7fd-c637-5447-e053-2995a90a5a6f2025-02-26WarningsExact identifier
application number: M022
Glorysmile Toothpaste.GLORYSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd2ef48156-904d-e42a-e063-6394a90a3cd02025-02-25WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWalgreensc4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa2025-02-21WarningsExact identifier
application number: M022
Sheffield Pain ReliefBENZOCAINESheffield Pharmaceuticals LLCe21abfdd-373d-42af-9535-fe1571382a652025-02-19WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWhole Foods Marketa2bb142e-8cbe-481e-bf4f-810ca6d145912025-02-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN82bc95be-0a07-3f00-e053-2a91aa0a743824
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD82bc95be-0a07-3f00-e053-2a91aa0a743824
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY82bc95be-0a07-3f00-e053-2a91aa0a743824
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY82bc95be-0a07-3f00-e053-2a91aa0a743824
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY82bc95be-0a07-3f00-e053-2a91aa0a743824
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY82bc95be-0a07-3f00-e053-2a91aa0a743824
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY82bc95be-0a07-3f00-e053-2a91aa0a743824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-514-09412500514091 TUBE in 1 CARTON (41250-514-09) / 113 g in 1 TUBE1 tube2019-02-252028-03-31NoNoCurrent