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 4 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Chocolate MintGINGICAINE GEL, CHOCOLATE MINT FLAVORGingi-Pak a Division of the Belport6285c4f2-c139-49a9-e053-2991aa0a2b032026-06-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Bellport Company, Inc. dba Gingi-Pakf5dd8fa8-0b6a-5a30-e053-2995a90ad1942026-06-26WarningsExact identifier
application number: M022
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
application number: M022
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
application number: M022
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
application number: M022
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
application number: M022
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsExact identifier
application number: M022
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
application number: M022
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
application number: M022
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
application number: M022
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
application number: M022
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
application number: M022
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
application number: M022
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact identifier
application number: M022
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact 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