FDA.reportPublic FDA data

Hydrogen Peroxide

Product NDC
68016-871
Requested package NDC
68016-871-45
11-digit product format
680160871
Labeler code
68016
Product ID
68016-871_d2ce080f-2bd7-4888-9450-ab2f3b1c3a00
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2003-08-13
Marketing end
0000-00-00
Substance
HYDROGEN PEROXIDE
Active strength
30 mg/mL
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 packagepackage68016-87168016-871-45DDiscontinued by firm2026-10-05

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9VHYDROGEN PEROXIDE SOLUTION [CHAIN DRUG CONSORTIUM, LLC]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VHYDROGEN PEROXIDE SOLUTION [CHAIN DRUG CONSORTIUM, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROGEN PEROXIDE SOLUTION [CHAIN DRUG CONSORTIUM, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-871HYDROGEN PEROXIDE SOLUTION [PHARMACY VALUE ALLIANCE LLC]14Legacy NDC20240928_a055003d-2ea6-48f9-afa7-87d545447cd8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-871-4568016087145946 mL in 1 BOTTLE, PLASTIC (68016-871-45) 946 ml2003-08-130000-00-00NoNoCurrent