FDA.reportPublic FDA data

Aplicare Hydrogen Peroxide

Product NDC
52380-0013
Requested package NDC
52380-0013-1
11-digit product format
523800013
Labeler code
52380
Product ID
52380-0013_d66ee7f7-132f-5178-e053-2995a90a1e12
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Aplicare Products, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1983-12-01
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 packagepackage52380-001352380-0013-1DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-0013-1Aplicare Hydrogen Peroxide30 mL in 1 PACKETLIQUID309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0013-1ML - Milliliter52380-0013f923cd3a-05c1-4992-8cda-be97c9b3590512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrogen PeroxideACTIVE INGREDIENTBBX060AN9VAPLICARE HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [APLICARE, INC.]1
Hydrogen PeroxideACTIVE MOIETYBBX060AN9VAPLICARE HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [APLICARE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RAPLICARE HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [APLICARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-0013APLICARE HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [APLICARE PRODUCTS, LLC]9Legacy NDC, 1 package rows20231019_eca20774-4f35-448f-9e22-ad93d0e818c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
91349hydrogen peroxide 3 % Topical SolutionPSNeca20774-4f35-448f-9e22-ad93d0e818c29
91349hydrogen peroxide 30 MG/ML Topical SolutionSCDeca20774-4f35-448f-9e22-ad93d0e818c29
91349hydrogen peroxide 3 % Topical SolutionSYeca20774-4f35-448f-9e22-ad93d0e818c29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52380-0013-15238000130130 mL in 1 PACKET (52380-0013-1) 30 ml1983-12-010000-00-00NoNoCurrent