FDA.reportPublic FDA data

Hydrogen Peroxide

Product NDC
0404-0001
11-digit product format
004040001
Labeler code
0404
Product ID
0404-0001_47e66953-6cd5-9f40-e063-6294a90a48a3
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Henry Schein Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-01
Substance
HYDROGEN PEROXIDE
Active strength
30 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrogen Peroxide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBBX060AN9V
Rxcui91349

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0001-01Hydrogen Peroxide3785 mL in 1 BOTTLE, PLASTICSOLUTION378512
0404-0001-08Hydrogen Peroxide237 mL in 1 BOTTLE, PLASTICSOLUTION23712
0404-0001-16Hydrogen Peroxide473 mL in 1 BOTTLE, PLASTICSOLUTION47312

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrogen PeroxideACTIVE INGREDIENTBBX060AN9VHYDROGEN PEROXIDE SOLUTION [HENRY SCHEIN INC.]1
Hydrogen PeroxideACTIVE MOIETYBBX060AN9VHYDROGEN PEROXIDE SOLUTION [HENRY SCHEIN INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RHYDROGEN PEROXIDE SOLUTION [HENRY SCHEIN INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0001HYDROGEN PEROXIDE SOLUTION [HENRY SCHEIN INC.]11Current NDC, Legacy NDC, 3 package rows20241116_d97671f0-b182-4dab-87d2-cf9919509da5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
91349hydrogen peroxide 3 % Topical SolutionPSNd97671f0-b182-4dab-87d2-cf9919509da512
91349hydrogen peroxide 30 MG/ML Topical SolutionSCDd97671f0-b182-4dab-87d2-cf9919509da512
91349hydrogen peroxide 3 % Topical SolutionSYd97671f0-b182-4dab-87d2-cf9919509da512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0001-01004040001013785 mL in 1 BOTTLE, PLASTIC (0404-0001-01) 3785 ml2014-06-010000-00-00NoNoCurrent
0404-0001-0800404000108237 mL in 1 BOTTLE, PLASTIC (0404-0001-08) 237 ml2014-06-010000-00-00NoNoCurrent
0404-0001-1600404000116473 mL in 1 BOTTLE, PLASTIC (0404-0001-16) 473 ml2014-06-010000-00-00NoNoCurrent