FDA.reportPublic FDA data

NDC 55346-3501-01 - PEROXY SHIELD MOUTH SORE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55346-3501
Requested NDC
55346-3501-01
Package NDCs from labels
55346-3501-1, 55346-3501-2, 55346-3501-01
Manufacturer
Dental Technologies, Inc.
Effective date
2025-11-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Peroxy Shield - MintDental Technologies, Inc.2025-11-04HUMAN OTC DRUG LABEL

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 41 of 162 · 3,239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL7-Eleven5625ac4e-aa37-41b5-80b7-67b223707ccf2026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET POTENT PAIN RELIEF45c76956-db3f-3e84-e063-6394a90adce12026-01-29WarningsExact identifier
unii: L7T10EIP3A
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAldi, Inc08aef3fa-f863-4716-ac72-1d7bfcc0d6ef2026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC498cd2aa-ee59-67b5-e063-6294a90ac2422026-01-29WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC498d76d8-788b-4cc7-e063-6294a90a16962026-01-29WarningsExact identifier
unii: L7T10EIP3A
Hydrogen PeroxideHYDROGEN PEROXIDEAmerifoods Trading Co38b15693-7e5f-4c85-915e-9937ea018a832026-01-29Warnings, Adverse reactionsExact identifier
unii: BBX060AN9V
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAMERISOURCE BERGEN02ffe892-732b-4798-9ea8-ca646c37f3002026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBelmora LLC3622e072-2784-c57e-e063-6394a90a82172026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCardinal Health, 110 dba Leaderd176eebb-4870-4206-a52e-f581ecaff4002026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Hydrogen PeroxideHYDROGEN PEROXIDECardinal Health, 110 dba Leaderd1418649-9490-4dab-b89c-9de6bb7196422026-01-29WarningsExact identifier
unii: BBX060AN9V
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International4ca91b34-a3ba-4c23-8bfb-473342ac42a22026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International98471185-3798-412f-b9b4-47f1971fbc7c2026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International035e82fc-75eb-474d-88ce-771e60e621792026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Hydrogen PeroxideHYDROGEN PEROXIDECariba International2c48f58a-a2d1-4a28-8dbf-a9d2c620bca62026-01-29Warnings, Adverse reactionsExact identifier
unii: BBX060AN9V
MQUPIN Lidocaine Gel-PatchLIDOCAINE GEL-PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49703717-69a6-e480-e063-6394a90ac69c2026-01-28WarningsExact identifier
unii: L7T10EIP3A
MQXUNMI LIDOCAINE Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49706db7-bacd-190f-e063-6394a90a3a8e2026-01-28WarningsExact identifier
unii: L7T10EIP3A
Joint and Muscle Relief Topical AnalgesicMENTHOLSmart Cookie Solutions1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d2026-01-28WarningsExact identifier
unii: L7T10EIP3A
Flobow QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD495b10ce-3d2d-1aa4-e063-6294a90a4f352026-01-27WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.