FDA.reportPublic FDA data

PEROXY SHIELD MOUTH SORE

Product NDC
55346-3501
11-digit product format
553463501
Labeler code
55346
Product ID
55346-3501_42c86f95-5c63-ba41-e063-6294a90af8c6
Type
HUMAN OTC DRUG
Nonproprietary name
1.5% Hydrogen Peroxide
Dosage form
RINSE
Route
ORAL
Labeler
Dental Technologies, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-03
Substance
HYDROGEN PEROXIDE
Active strength
1.5 mL/100mL
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
PEROXY SHIELD MOUTH SORE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE1.5 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BBX060AN9VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199011Internal RxNorm lookup
2480895Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a72e433b-1b7d-4a0c-e053-2995a90a30c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-3501-1PEROXY SHIELD MOUTH SORE1863 mL in 1 BOTTLE, PLASTICRINSE18635
55346-3501-2PEROXY SHIELD MOUTH SORE473 mL in 1 BOTTLERINSE4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-3501PEROXY SHIELD MOUTH SORE (1.5% HYDROGEN PEROXIDE) RINSE [DENTAL TECHNOLOGIES, INC.]4Current NDC, Legacy NDC, 2 package rows20231220_a72e433b-1b7d-4a0c-e053-2995a90a30c4.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
199011hydrogen peroxide 1.5 % Oral SolutionPSNa72e433b-1b7d-4a0c-e053-2995a90a30c45
2480895PEROXY SHIELD 1.5 % Oral SolutionPSNa72e433b-1b7d-4a0c-e053-2995a90a30c45
2480895hydrogen peroxide 15 MG/ML Oral Solution [Peroxy Shield]SBDa72e433b-1b7d-4a0c-e053-2995a90a30c45
199011hydrogen peroxide 15 MG/ML Oral SolutionSCDa72e433b-1b7d-4a0c-e053-2995a90a30c45
199011hydrogen peroxide 1.5 % Oral SolutionSYa72e433b-1b7d-4a0c-e053-2995a90a30c45
2480895Peroxy Shield 1.5 % Oral SolutionSYa72e433b-1b7d-4a0c-e053-2995a90a30c45
2480895Peroxy Shield 15 MG/ML Oral SolutionSYa72e433b-1b7d-4a0c-e053-2995a90a30c45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55346-3501-1553463501011863 mL in 1 BOTTLE, PLASTIC (55346-3501-1) 1863 ml2020-06-120000-00-00NoNoCurrent
55346-3501-255346350102473 mL in 1 BOTTLE (55346-3501-2) 473 ml2021-11-240000-00-00NoNoCurrent