FDA.reportPublic FDA data

Hydrogen Peroxide

Product NDC
53175-001
Requested package NDC
53175-001-04
11-digit product format
531750001
Labeler code
53175
Product ID
53175-001_fb4c85f9-5bbf-4296-8cfd-fe7d4104a19a
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Dyad Medical Sourcing, LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-09-10
Marketing end
0000-00-00
Substance
HYDROGEN PEROXIDE
Active strength
3 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53175-00153175-001-04IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53175-001-04Hydrogen Peroxide118 mL in 1 BOTTLELIQUID11811
53175-001-08Hydrogen Peroxide237 mL in 1 BOTTLELIQUID23711
53175-001-16Hydrogen Peroxide473 mL in 1 BOTTLELIQUID47311

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrogen PeroxideACTIVE INGREDIENTBBX060AN9VHYDROGEN PEROXIDE LIQUID [DYAD MEDICAL SOURCING, LLC]1
Hydrogen PeroxideACTIVE MOIETYBBX060AN9VHYDROGEN PEROXIDE LIQUID [DYAD MEDICAL SOURCING, LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RHYDROGEN PEROXIDE LIQUID [DYAD MEDICAL SOURCING, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53175-001HYDROGEN PEROXIDE LIQUID [DYAD MEDICAL SOURCING, LLC]11Legacy NDC, 3 package rows20241116_1e7c47f2-c4ea-4853-b597-d0e5e002a202.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
91349hydrogen peroxide 3 % Topical SolutionPSN1e7c47f2-c4ea-4853-b597-d0e5e002a20211
91349hydrogen peroxide 30 MG/ML Topical SolutionSCD1e7c47f2-c4ea-4853-b597-d0e5e002a20211
91349hydrogen peroxide 3 % Topical SolutionSY1e7c47f2-c4ea-4853-b597-d0e5e002a20211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53175-001-0453175000104118 mL in 1 BOTTLE (53175-001-04) 118 ml2012-09-100000-00-00NoNoCurrent