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

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 Identifiers#

Field, Values table
FieldValues
UniiBBX060AN9V
Rxcui199011, 2480895

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

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