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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
application number: M022
Dual-FormulaToothpaste for sensitive teethDUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETHHangzhou Namei Zhikang Technology Co., Ltd.4d735f91-8abc-3a30-e063-6394a90a76392026-03-20WarningsExact identifier
application number: M022
SmileCare Mouth Ulcer GelMENTHOLYantai Aien Biotechnology Co., Ltd.4d6db039-5b97-8f3f-e063-6294a90a9d852026-03-19WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f91e609-8ca5-0492-e053-2a95a90a85d02026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f81ffa5-05fd-4eef-e053-2995a90aac3e2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947366-9380-3fa9-e053-2a95a90ad49c2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947672-4873-5546-e053-2a95a90a3c4b2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f9490c1-8bfe-3166-e053-2a95a90a71752026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f94b65d-47e3-9c6b-e053-2a95a90aa1f82026-03-17WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c00a6-1346-7780-e063-6294a90a3d5a2026-03-12WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINENantong Health & Beyond Hygienic Products Inc.a5f0be98-d47e-4307-8044-304a64db774b2026-03-11WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDECVS Pharmacy, Inc.a5dbaadf-76a8-4c48-af2d-f4455e9411f02026-03-09Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDESam's West, Inc78a3e024-73da-40b7-9d9c-099fd6ca9b9e2026-03-03WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
application number: M022
Spring Gene Oil Pulling SensitivityPOTASSIUM NITRATEHealth and Natural Beauty USA Corp294051e3-69ec-4190-8b03-fa34988376b72026-02-26WarningsExact identifier
application number: M022
Lolleez WatermelonPECTINBFY LLC4ba8af8b-5a17-8b8c-e063-6394a90a63f32026-02-25WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLH E Bf1450866-1be4-46d9-9fe4-52d699636b4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact 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