FDA.reportPublic FDA data

3% HYDROGEN PEROXIDE

Product NDC
84809-005
11-digit product format
848090005
Labeler code
84809
Product ID
84809-005_3b9d65a2-39a5-08f0-e063-6394a90a4c91
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
LJ Pharma
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-30
Substance
HYDROGEN PEROXIDE
Active strength
3 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
3% HYDROGEN PEROXIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE3 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBBX060AN9V
Rxcui91349

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84809-005-013% HYDROGEN PEROXIDE236 mL in 1 BOTTLE, SPRAYLIQUID2362
84809-005-013% HYDROGEN PEROXIDE12 in 1 CARTONLIQUID122
84809-005-023% HYDROGEN PEROXIDE473 mL in 1 BOTTLE, SPRAYLIQUID4732
84809-005-023% HYDROGEN PEROXIDE12 in 1 CARTONLIQUID122
84809-005-033% HYDROGEN PEROXIDE946 mL in 1 BOTTLE, SPRAYLIQUID9462
84809-005-033% HYDROGEN PEROXIDE12 in 1 CARTONLIQUID122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
91349hydrogen peroxide 3 % Topical SolutionPSNe468ad76-b26a-49f0-a2c5-a027299babc72
91349hydrogen peroxide 30 MG/ML Topical SolutionSCDe468ad76-b26a-49f0-a2c5-a027299babc72
91349hydrogen peroxide 3 % Topical SolutionSYe468ad76-b26a-49f0-a2c5-a027299babc72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84809-005-018480900050112 BOTTLE, SPRAY in 1 CARTON (84809-005-01) / 236 mL in 1 BOTTLE, SPRAY2025-06-30NoNoHistorical
84809-005-028480900050212 BOTTLE, SPRAY in 1 CARTON (84809-005-02) / 473 mL in 1 BOTTLE, SPRAY2025-06-30NoNoHistorical
84809-005-038480900050312 BOTTLE, SPRAY in 1 CARTON (84809-005-03) / 946 mL in 1 BOTTLE, SPRAY2025-08-04NoNoHistorical