Home NDC 55346-3501 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 Ingredient Strength HYDROGEN PEROXIDE 1.5 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BBX060AN9V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199011 Internal RxNorm lookup 2480895 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55346-3501-1 PEROXY SHIELD MOUTH SORE 1863 mL in 1 BOTTLE, PLASTIC RINSE 1863 5 55346-3501-2 PEROXY SHIELD MOUTH SORE 473 mL in 1 BOTTLE RINSE 473 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55346-3501 PEROXY SHIELD MOUTH SORE (1.5% HYDROGEN PEROXIDE) RINSE [DENTAL TECHNOLOGIES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20231220_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 29 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55346-3501-1 55346350101 1863 mL in 1 BOTTLE, PLASTIC (55346-3501-1) 1863 ml 2020-06-12 0000-00-00 No No Current 55346-3501-2 55346350102 473 mL in 1 BOTTLE (55346-3501-2) 473 ml 2021-11-24 0000-00-00 No No Current