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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
application number: M022
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
application number: M022
SEXYTEETH CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
application number: M022
Gingicaine Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
application number: M022
3ECARE Dual formula WhiteningToothpaste RefillSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.501df1c7-4884-bb39-e063-6294a90aaf6a2026-04-23WarningsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
application number: M022
EverSmile AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
application number: M022
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
application number: M022
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
application number: M022
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsExact identifier
application number: M022
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsExact 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